A Phase 1 interventional study of Carboplatin and Paclitaxel in Advanced Esophageal Adenocarcinoma, Advanced Gastroesophageal Junction Adenocarcinoma and Clinical Stage II Esophageal Adenocarcinoma AJCC v8, sponsored by NRG Oncology. Active, not recruiting at 17 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-01.
Sponsored by NRG Oncology · Phase 1, Interventional, and Treatment
This phase I trial studies the side effects of OBP-301 when given together with carboplatin, paclitaxel, and radiation therapy in treating patients with esophageal or gastroesophageal cancer that invades local or regional structures. OBP-301 is a virus that has been designed to infect and destroy tumor cells (although there is a small risk that it can also infect normal cells). Chemotherapy drugs, such as carboplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving OBP-301 with chemotherapy and radiation therapy may work better than standard chemotherapy and radiation therapy in treating patients with esophageal or gastroesophageal cancer.
PRIMARY OBJECTIVE:
I. To determine if the addition of OBP-301 to chemoradiation with carboplatin/paclitaxel is safe.
SECONDARY OBJECTIVES:
I. To assess toxicities associated with the addition of OBP-301 to chemoradiation.
II. To assess the number of clinical complete responses (cCR).
III. To assess the number of patients alive/without progression (progression-free survival [PFS]) and the number of patients alive (overall survival [OS]) at 1 and 2 years.
EXPLORATORY OBJECTIVE:
I. To report correlate outcomes - cCR, PFS and OS - with immune and virus-based correlative assays.
OUTLINE:
This study will evaluate an initial dose of OBP-301 and a de-escalated dose, if needed.
Patients receive OBP-301 by intratumoral injection via endoscopy on days -3, 12, and 26. Patients also receive carboplatin intravenously (IV) over 30 minutes and paclitaxel IV over 60 minutes on days 1, 8, 15, 22, and 29, and undergo radiation therapy on Monday through Friday beginning day 1 for 28 fractions over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 and 6-8 weeks, then every 3 months for 2 years.
627 studies on the registry are indexed under Carcinoma, Squamous Cell; 133 are open to participants now.
This study's enrollment of 16 is below the median of 45 across 476 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →NRG Oncology is the lead sponsor of 72 studies on the registry; 25 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.
Pathologically (histologically or cytologically) proven diagnosis of adenocarcinoma or squamous cell carcinoma (SCC) of the esophagus or gastroesophageal junction (GEJ) within 90 days prior to registration
Required diagnostic workup for study entry:
Known acute or chronic or C infection (testing not required prior to study entry in patients with no known history of hepatitis B or C)
Exclusion Criteria:
Definitive clinical or radiologic evidence of disease including:
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
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.
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.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
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.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
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.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
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.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and 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.
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.
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.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive OBP-301 (1×10\^12 vp/mL) by intra-tumoral injection via endoscopy on days -3, 12, and 26. Patients also receive paclitaxel IV (50 mg/m\^2) over 60 minutes followed by carboplatin IV (AUC 2) over 30 minutes and on days 1, 8, 15, 22, and 29, and undergo radiation therapy (1.8 Gy/faction) on Monday through Friday beginning day 1 for 28 fractions (50.4 Gy total) over 5.5 weeks. All treatment continues in the absence of disease progression or unacceptable toxicity.
Drug: Carboplatin · Drug: Paclitaxel · Radiation: Radiation Therapy · Biological: Telomerase-specific Type 5 Adenovirus OBP-301
Intravenously (IV)
Also known as: Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carboplatinum, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo
Intravenously (IV)
Also known as: Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat
Daily fractions
Also known as: Cancer Radiotherapy, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, RADIOTHERAPY, RT, Therapy, Radiation
Intra-tumoral injection
Also known as: OBP-301, Telomelysin ™
Number of Participants Experiencing Any Dose-Limiting Toxicities (DLTs)
Adverse events are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. A DLT is defined as the following that are definitely or probably attributed to OBP-301: * Any grade ≥3 adverse event EXCEPT for the following: * Grade 3 nausea/vomiting * Grade 3 esophagitis or dehydration * The first occurrence of grade 3/4 neutropenia * Grade 3/4 lymphopenia (since this is a known toxicity of chemoradiation and OBP-301) * Any toxicity that leads to a \>14-day cumulative delay in chemoradiation. If 0 or 1 participants of 6 participants experienced a DLT, then the treatment regimen would be considered safe (and 9 more would be accrued for secondary endpoints). Otherwise, the regimen would be deemed too toxic and a second cohort of six participants would be accrued to a lower dose of OBP-301 (1 x 10\^11 vp/mL).
Time frame: From start of protocol treatment until 30 days after the completion of chemoradiation, approximately 10 weeks.
Number of Participants by Highest Grade Adverse Event Reported
The Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
Time frame: From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months.
Number of Participants With Clinical Complete Response (cCR)
Clinical complete response is defined as grossly free of disease as determined by a visual inspection or if the visual inspection was not certain, then a negative biopsy. The number of participants is determined for two populations: * Complete case analysis only includes eligible participants who started protocol treatment and were assessed for cCR; * Sensitivity analysis includes all eligible participants who started protocol treatment and counts participants without an assessment as not achieving a cCR.
Time frame: 6-8 weeks after completion of chemoradiation, approximately 11.5-13.5 weeks from baseline.
Number of Participants Alive Without Progression at 1 and 2 Years
Progression is defined as pathologically confirmed recurrence of local disease or clinical evidence of distant disease.
Time frame: At 1 and 2 years
Number of Participants Alive at 1 and 2 Years
Time frame: At 1 and 2 years
| Milestone | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| Started | 16 |
| Completed | 15 |
| Not completed | 1 |
| Withdrew: Protocol violation | 1 |
Adverse events are graded according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. A DLT is defined as the following that are definitely or probably attributed to OBP-301: * Any grade ≥3 adverse event EXCEPT for the following: * Grade 3 nausea/vomiting * Grade 3 esophagitis or dehydration * The first occurrence of grade 3/4 neutropenia * Grade 3/4 lymphopenia (since this is a known toxicity of chemoradiation and OBP-301) * Any toxicity that leads to a \>14-day cumulative delay in chemoradiation. If 0 or 1 participants of 6 participants experienced a DLT, then the treatment regimen would be considered safe (and 9 more would be accrued for secondary endpoints). Otherwise, the regimen would be deemed too toxic and a second cohort of six participants would be accrued to a lower dose of OBP-301 (1 x 10\^11 vp/mL).
| Participants | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| Number of Participants Experiencing Any Dose-Limiting Toxicities (DLTs) | 0 |
The Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grades adverse event severity as follows: 1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, 5 = death related to adverse event. Summary data is provided in this outcome measure; see Adverse Events Module for specific adverse event data.
| Participants | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| All adverse events — None reported | 0 |
| All adverse events — Grade 1 | 1 |
| All adverse events — Grade 2 | 1 |
| All adverse events — Grade 3 | 7 |
| All adverse events — Grade 4 | 4 |
| All adverse events — Grade 5 | 2 |
| Definitely or probably related to any protocol treatment — None reported | 1 |
| Definitely or probably related to any protocol treatment — Grade 1 | 3 |
| Definitely or probably related to any protocol treatment — Grade 2 | 1 |
| Definitely or probably related to any protocol treatment — Grade 3 | 8 |
| Definitely or probably related to any protocol treatment — Grade 4 | 1 |
| Definitely or probably related to any protocol treatment — Grade 5 | 1 |
| Definitely or probably related to OBP-301 protocol treatment — None reported | 7 |
| Definitely or probably related to OBP-301 protocol treatment — Grade 1 | 2 |
| Definitely or probably related to OBP-301 protocol treatment — Grade 2 | 5 |
| Definitely or probably related to OBP-301 protocol treatment — Grade 3 | 0 |
| Definitely or probably related to OBP-301 protocol treatment — Grade 4 | 1 |
| Definitely or probably related to OBP-301 protocol treatment — Grade 5 | 0 |
Clinical complete response is defined as grossly free of disease as determined by a visual inspection or if the visual inspection was not certain, then a negative biopsy. The number of participants is determined for two populations: * Complete case analysis only includes eligible participants who started protocol treatment and were assessed for cCR; * Sensitivity analysis includes all eligible participants who started protocol treatment and counts participants without an assessment as not achieving a cCR.
| Participants | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| Complete Case Analysis | 13 |
| Sensitivity Analysis | 13 |
Progression is defined as pathologically confirmed recurrence of local disease or clinical evidence of distant disease.
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Collected over From start of protocol treatment to last follow-up. Maximum follow-up was 28.7 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) | 5/15 (33.3%) | 7/15 (46.7%) | 15/15 (100%) |
| Event | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| SepsisInfections and infestations | 2/15 |
| Atrial fibrillationCardiac disorders | 1/15 |
| Esophageal fistulaGastrointestinal disorders | 1/15 |
| Esophageal stenosisGastrointestinal disorders | 1/15 |
| FeverGeneral disorders | 1/15 |
| Lung infectionInfections and infestations | 1/15 |
| FallInjury, poisoning and procedural complications | 1/15 |
| Neutrophil count decreasedInvestigations | 1/15 |
| DehydrationMetabolism and nutrition disorders | 1/15 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 1/15 |
| Event | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| FatigueGeneral disorders | 13/15 |
| Lymphocyte count decreasedInvestigations | 12/15 |
| White blood cell decreasedInvestigations | 12/15 |
| AnemiaBlood and lymphatic system disorders | 10/15 |
| ConstipationGastrointestinal disorders | 9/15 |
| NauseaGastrointestinal disorders | 9/15 |
| Neutrophil count decreasedInvestigations | 9/15 |
| DiarrheaGastrointestinal disorders | 8/15 |
| Platelet count decreasedInvestigations | 8/15 |
| HyponatremiaMetabolism and nutrition disorders | 8/15 |
Eligible participants who started treatment.
| Age, Continuous(years) | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| Median | 74 (62 to 87) |
| Sex: Female, Male(Participants) | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| Female | 3 |
| Male | 12 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 13 |
| Unknown or Not Reported | 1 |
| Race (NIH/OMB)(Participants) | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 15 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Zubrod Performance Status(Participants) | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| 0 (Asymptomatic) | 6 |
| 1 (Symptomatic but completely ambulatory) | 9 |
| Histologic Type(Participants) | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| Adenocarcinoma | 11 |
| Squamous cell carcinoma | 4 |
| Tumor Location(Participants) | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| Esophagogastric junction | 3 |
| Esophagus | 12 |
| Siewert Type for Esophagogastric Junction(Participants) | Treatment (OBP-301, Carboplatin, Paclitaxel, Radiation) |
|---|---|
| Type I | 2 |
| Type II | 1 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2021 to primary completion in Oct 2024, 34 months.
Results were first posted in May 2025, 7 months after primary completion.
Of 42 phase 1 interventional studies under Carcinoma, Squamous Cell, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 62. This study's 34 months is below that.
Completion moved once since we started tracking on Sep 25, 2026: Oct 2030 → Oct 2029, on Oct 1, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Suratadenoturev
NRG Oncology