A Phase 3 interventional study of NovoTTF-200T and Gemcitabine in Pancreas Adenocarcinoma, sponsored by NovoCure Ltd.. Completed at 199 sites in 20 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-21.
Sponsored by NovoCure Ltd. · Phase 3, Interventional, and Treatment
Brief Summary:
The study is a prospective, randomized controlled phase III trial aimed to test the efficacy and safety of Tumor Treating Fields (TTFields) in combination with gemcitabine and nab-paclitaxel, for front line treatment of locally-advanced pancreatic adenocarcinoma.The device is an experimental, portable, battery operated device for chronic administration of alternating electric fields (termed TTFields or TTF) to the region of the malignant tumor, by means of surface, insulated electrode arrays.
PAST PRE-CLINICAL AND CLINICAL EXPERIENCE:
The effect of the electric fields (TTFields, TTF) has demonstrated significant activity in in vitro and in vivo pancreatic adenocarcinoma pre-clinical models both as a single modality treatment and in combination with chemotherapies. TTFields have been demonstrated to act synergistically with taxanes and have been shown to be additive when combined with other chemotherapies including gemcitabine. In addition, TTFields have shown to inhibit metastatic spread of malignant melanoma in in vivo experiment.
In a pilot study, 40 patients with locally advanced or metastatic pancreatic adenocarcinoma received gemcitabine together with TTFields (150 kHz) or gemcitabine and nab-paclitaxel together with TTFields (150 kHz) applied to the abdomen until disease progression. The combination was well tolerated and the only device-related adverse event was contact dermatitis.
In addition, a phase III trial of Optune® (200 kHz) as monotherapy compared to active chemotherapy in recurrent glioblastoma patients showed TTFields to be equivalent to active chemotherapy in extending survival, associated with minimal toxicity, good quality of life, and activity within the brain (14% response rate) (Stupp R., et al., EJC 2012). Finally, a phase III trial of Optune® combined with maintenance temozolomide compared to maintenance temozolomide alone has shown that combined therapy led to a significant improvement in both progression free survival and overall survival in patients with newly diagnosed glioblastoma without the addition of high grade toxicity and without decline in quality of life (Stupp R., et al., JAMA 2017).
DESCRIPTION OF THE TRIAL:
All patients included in this trial are patients with locally advanced pancreatic adenocarcinoma. In addition, all patients must meet all eligibility criteria.
Eligible patients will be randomly assigned to one of two groups:
Patients will be randomized at a 1:1 ratio. Baseline tests will be performed in patients enrolled in both arms. If assigned to the NovoTTF-200T group, the patients will be treated continuously with the device until progression in the abdomen. On both arms, patients who have progression outside the abdomen will switch to a second line treatment according to local practice.
SCIENTIFIC BACKGROUND:
Electric fields exert forces on electric charges similar to the way a magnet exerts forces on metallic particles within a magnetic field. These forces cause movement and rotation of electrically charged biological building blocks, much like the alignment of metallic particles seen along the lines of force radiating outwards from a magnet.
Electric fields can also cause muscles to twitch and if strong enough may heat tissues. TTFields are alternating electric fields of low intensity. This means that they change their direction repetitively many times a second. Since they change direction very rapidly (150 thousand times a second), they do not cause muscles to twitch, nor do they have any effects on other electrically activated tissues in the body (brain, nerves and heart). Since the intensities of TTFields in the body are very low, they do not cause heating.
The breakthrough finding made by Novocure was that finely tuned alternating fields of very low intensity, now termed TTFields (Tumor Treating Fields), cause a significant slowing in the growth of cancer cells. Due to the unique geometric shape of cancer cells when they are multiplying, TTFields cause electrically-charged cellular components of these cells to change their location within the dividing cell, disrupting their normal function and ultimately leading to cell death. In addition, cancer cells also contain miniature building blocks which act as tiny motors in moving essential parts of the cells from place to place. TTFields interfere with the normal orientation of these tiny motors related to other cellular components since they are electrically-charged as well. As a result of these two effects, tumor cell division is slowed, results in cellular death or reverses after continuous exposure to TTFields.
Other cells in the body (normal healthy tissues) are affected much less than cancer cells since they multiply at a much slower rate if at all. In addition TTFields can be directed to a certain part of the body, leaving sensitive areas out of their reach. Finally, the frequency of TTFields applied to each type of cancer is specific and may not damage normally dividing cells in healthy tissues.
In conclusion, TTFields hold the promise of serving as a brand new treatment for pancreatic adenocarcinoma with very few side effects.
NovoCure Ltd. is the lead sponsor of 19 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Unresectable, locally advanced stage disease according to the following criteria:
Head/uncinate process:
Body and tail
Exclusion Criteria:
Serious co-morbidities:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive TTFields using the NovoTTF-200T System together with gemcitabine and nab-Paclitaxel
Device: NovoTTF-200T · Drug: Gemcitabine · Drug: nab paclitaxel
Patients receive best standard of care with gemcitabine and nab-Paclitaxel
Drug: Gemcitabine · Drug: nab paclitaxel
Patients receive continuous TTFields treatment using the NovoTTF-200T device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
Also known as: TTFields
Gemcitabine 1000 mg/m\^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.
nab-paclitaxel 125 mg/m\^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.
Overall Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Overall survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to overall survival of subjects treated with chemotherapy alone, measured as the period between the time of randomization and the time of death.
Time frame: From randomization until death from any cause or last known alive.
Progression-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Progression-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the progression-free survival of subjects treated with chemotherapy alone, measured from the time of randomization and based on CT scans collected on the study, using the revised RECIST V1.1 Criteria. Progression is defined using the RECIST 1.1 criteria: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, in addition the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, progression was defined as unequivocal progression (an overall level of substantial worsening in non-target disease) of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
Time frame: From randomization until radiologic disease progression per RECIST v1.1 or death, whichever occurs first.
Local Progression-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Local progression-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the local progression-free survival of subjects treated with chemotherapy alone, measured from the time of randomization and based on CT scans collected on the study, using the revised RECIST V1.1 Criteria. Local progression is defined per RECIST 1.1 in the absence of distant metastasis: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, in addition the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, progression was defined as unequivocal progression (an overall level of substantial worsening) of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
Time frame: From randomization until local disease progression per RECIST v1.1 (in the absence of distant metastasis) or death, whichever occurs first.
Objective Response Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Objective Response Rate (ORR) was assessed per RECIST v1.1. Complete Response (CR): disappearance of all target and non-target lesions and reduction of pathological lymph nodes to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions from baseline without new lesions or progression of non-target lesions. ORR is defined as the percentage of participants whose best overall response was CR or PR.
Time frame: From randomization until radiologic disease progression per RECIST v1.1 or end of tumor assessment follow-up.
One-year Survival Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
One-year survival rate of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the 1-year survival rate of subjects treated with chemotherapy alone.
Time frame: From randomization through 12 months after randomization.
Quality of Life of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Quality of life deterioration-free survival (DFS) was assessed using the EORTC QLQ-C30 and pancreatic cancer-specific QLQ-PAN26 questionnaires. Higher scores on functional and global health status scales indicate better functioning, whereas higher symptom scores indicate worse symptoms. DFS was defined as the time from randomization to the first ≥10-point deterioration from baseline without a subsequent ≥10-point improvement, or death. DFS was evaluated separately for each QoL domain included in the analysis.
Time frame: From randomization until the first ≥10-point deterioration without subsequent improvement, or death, assessed for the duration of study follow-up.
Pain-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Pain-free survival was measured as the duration between the time of randomization until a greater than or equal to twenty-point increase from baseline in a patient self-reported visual analogue scale (VAS) was recorded or death, whichever occurred first.
Time frame: From randomization until a ≥20-point increase from baseline in pain on the patient-reported visual analogue scale (0-100) or death, whichever occurs first.
Puncture-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Puncture-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to puncture-free survival of subjects treated with chemotherapy alone, measured as the duration between randomization until the first need for paracentesis or death, whichever occurs first.
Time frame: From randomization until the first paracentesis or death, whichever occurs first.
Resectability Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone
Resectability rate defined as the number and percentage of patients whose tumors were deemed resectable and who underwent surgery.
Time frame: From randomization through the end of study follow-up. Surgical resections were captured throughout study follow-up, up to approximately 18 months.
| Milestone | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| Started | 285 | 286 |
| Completed | 0 | 0 |
| Not completed | 285 | 286 |
| Withdrew: Death | 193 | 211 |
| Withdrew: Lost to follow-up | 2 | 3 |
| Withdrew: Withdrawal by subject | 42 | 26 |
| Withdrew: Study closure | 40 | 37 |
| Withdrew: Other | 8 | 9 |
Overall survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to overall survival of subjects treated with chemotherapy alone, measured as the period between the time of randomization and the time of death.
| Months | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| Overall Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone | 16.20 (15.01 to 17.97) | 14.16 (12.81 to 15.44) |
Progression-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the progression-free survival of subjects treated with chemotherapy alone, measured from the time of randomization and based on CT scans collected on the study, using the revised RECIST V1.1 Criteria. Progression is defined using the RECIST 1.1 criteria: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, in addition the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, progression was defined as unequivocal progression (an overall level of substantial worsening in non-target disease) of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
| Months | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| Progression-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone | 10.61 (9.20 to 12.19) | 9.33 (7.59 to 11.07) |
Local progression-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the local progression-free survival of subjects treated with chemotherapy alone, measured from the time of randomization and based on CT scans collected on the study, using the revised RECIST V1.1 Criteria. Local progression is defined per RECIST 1.1 in the absence of distant metastasis: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study, in addition the sum must also demonstrate an absolute increase of at least 5 mm. For non-target lesions, progression was defined as unequivocal progression (an overall level of substantial worsening) of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
| Months | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| Local Progression-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone | 12.45 (10.68 to 14.52) | 10.41 (9.13 to 11.79) |
Objective Response Rate (ORR) was assessed per RECIST v1.1. Complete Response (CR): disappearance of all target and non-target lesions and reduction of pathological lymph nodes to \<10 mm. Partial Response (PR): ≥30% decrease in the sum of diameters of target lesions from baseline without new lesions or progression of non-target lesions. ORR is defined as the percentage of participants whose best overall response was CR or PR.
| Participants | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| Objective Response Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone | 88 | 73 |
One-year survival rate of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to the 1-year survival rate of subjects treated with chemotherapy alone.
| percentage of subjects alive at 1 year | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| One-year Survival Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone | 68.1 (62.0 to 73.5) | 60.2 (54.2 to 65.7) |
Quality of life deterioration-free survival (DFS) was assessed using the EORTC QLQ-C30 and pancreatic cancer-specific QLQ-PAN26 questionnaires. Higher scores on functional and global health status scales indicate better functioning, whereas higher symptom scores indicate worse symptoms. DFS was defined as the time from randomization to the first ≥10-point deterioration from baseline without a subsequent ≥10-point improvement, or death. DFS was evaluated separately for each QoL domain included in the analysis.
| Months | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| Global health status / Quality of Life | 7.1 (5.7 to 9.4) | 5.7 (4.1 to 7.4) |
| Pain (EORTC QLQ-C30) | 10.1 (8.0 to 11.6) | 7.4 (5.9 to 9.0) |
| Pancreatic pain (EORTC QLQ-PAN26) | 14.7 (12.0 to 16.5) | 10.2 (8.8 to 12.2) |
| Digestive problems (EORTC QLQ-PAN26) | 8.3 (6.1 to 11.2) | 5.7 (4.4 to 7.4) |
Pain-free survival was measured as the duration between the time of randomization until a greater than or equal to twenty-point increase from baseline in a patient self-reported visual analogue scale (VAS) was recorded or death, whichever occurred first.
| Months | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| Pain-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone | 15.18 (10.28 to 22.77) | 9.13 (7.43 to 12.68) |
Puncture-free survival of subjects treated with TTFields concomitant with gemcitabine and nab-paclitaxel in the first line treatment of unresectable, locally advanced pancreatic cancer subjects, compared to puncture-free survival of subjects treated with chemotherapy alone, measured as the duration between randomization until the first need for paracentesis or death, whichever occurs first.
| months | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| Puncture-free Survival of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone | 22.8 (15.5 to NA) | 16.6 (13.1 to NA) |
Resectability rate defined as the number and percentage of patients whose tumors were deemed resectable and who underwent surgery.
| Participants | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| Resectability Rate of Subjects Treated With TTFields Concomitant With Gemcitabine and Nab-paclitaxel vs Chemotherapy Alone | 20 (4.3 to 10.6) | 29 (6.9 to 14.2) |
Collected over Adverse events were collected from randomization until last study follow up visit and for 30 days following treatment termination, estimated 4 years. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| TTFields + Standard of Care | 199/274 (72.6%) | 147/274 (53.6%) | 267/274 (97.4%) |
| Standard of Care | 223/273 (81.7%) | 131/273 (48%) | 268/273 (98.2%) |
| Event | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| SepsisInfections and infestations | 19/274 | 26/273 |
| CholangitisHepatobiliary disorders | 16/274 | 10/273 |
| Bile duct obstructionHepatobiliary disorders | 15/274 | 9/273 |
| PneumoniaInfections and infestations | 14/274 | 9/273 |
| AnaemiaBlood and lymphatic system disorders | 3/274 | 12/273 |
| PyrexiaGeneral disorders | 8/274 | 5/273 |
| InfectionInfections and infestations | 8/274 | 7/273 |
| VomitingGastrointestinal disorders | 4/274 | 7/273 |
| DiarrhoeaGastrointestinal disorders | 2/274 | 7/273 |
| DehydrationMetabolism and nutrition disorders | 0/274 | 7/273 |
| Event | TTFields + Standard of Care | Standard of Care |
|---|---|---|
| NeutropeniaBlood and lymphatic system disorders | 171/274 | 180/273 |
| FatigueGeneral disorders | 164/274 | 148/273 |
| AnemiaBlood and lymphatic system disorders | 161/274 | 155/273 |
| ThrombocytopeniaBlood and lymphatic system disorders | 122/274 | 132/273 |
| DiarrheaGastrointestinal disorders | 119/274 | 123/273 |
| NauseaGastrointestinal disorders | 107/274 | 121/273 |
| Neuropathy peripheralNervous system disorders | 112/274 | 81/273 |
| Peripheral edemaGeneral disorders | 107/274 | 99/273 |
| AnorexiaMetabolism and nutrition disorders | 93/274 | 101/273 |
| LeukopeniaBlood and lymphatic system disorders | 85/274 | 98/273 |
There may be more than 1 lesion present in a participant
| Age, Continuous(Years) | TTFields + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| Median | 67 (31 to 90) | 67.5 (40 to 88) | 67 (31 to 90) |
| Sex: Female, Male(Participants) | TTFields + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| Female | 138 | 161 | 299 |
| Male | 147 | 125 | 272 |
| Race/Ethnicity, Customized(Participants) | TTFields + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 9 | 4 | 13 |
| Asian | 44 | 44 | 88 |
| Black or African American | 16 | 14 | 30 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| White | 202 | 204 | 406 |
| Other | 3 | 5 | 8 |
| Not Reported | 11 | 15 | 26 |
| Region of Enrollment(Participants) | TTFields + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| North America | 123 | 125 | 248 |
| Eastern Europe | 43 | 42 | 85 |
| Western Europe and Israel | 62 | 61 | 123 |
| Rest of World | 57 | 58 | 115 |
| ECOG Performance Status(Participants) | TTFields + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| 0 | 109 | 111 | 220 |
| 1 | 166 | 163 | 329 |
| 2 | 10 | 12 | 22 |
| BMI Group(Participants) | TTFields + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| < 25 kg/m2 | 166 | 174 | 340 |
| ≥ 25 kg/m2 | 117 | 108 | 225 |
| Missing BMI | 2 | 4 | 6 |
| CA19.9(Participants) | TTFields + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| Low (≤37 U/mL) | 48 | 44 | 92 |
| Moderate (38-1,000 U/mL) | 140 | 152 | 292 |
| High (>1,000 U/mL) | 88 | 79 | 167 |
| Untested | 9 | 11 | 20 |
| Target Lesion Site(Lesions) | TTFields + Standard of Care | Standard of Care | Total |
|---|---|---|---|
| Head of Pancreas | 164 | 160 | 324 |
| Body of Pancreas | 82 | 81 | 163 |
| Tail of Pancreas | 9 | 19 | 28 |
| Other: Multiple regions in pancreas | 26 | 22 | 48 |
| Other: Extra-pancreatic | 29 | 27 | 56 |
Showing the first 100 of 199 sites across 20 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2018 to primary completion in Oct 2024, 77 months.
Results were first posted in Jan 2026, 1 year 3 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.