ClinicalTrials.gg
Not yet recruitingNCT07828756Updated Sep 18, 2026

Albumin-bound Paclitaxel (Ⅱ)-Combined Regimens for Pancreatic Cancer

A Phase 2 interventional study of Cisplatin and Albumin-bound Paclitaxel (Ⅱ) in Pancreatic Cancer, sponsored by Tianjin Medical University Cancer Institute and Hospital. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-18.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 2, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 2
Study type
Interventional
Enrollment
147
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-15

Among 131 studies testing Albumin-Bound Paclitaxel in Pancreatic Neoplasms — 22 open to participants now, 33 under way, 4 of them phase 3. Albumin-Bound Paclitaxel · Pancreatic Neoplasms.

Planned enrollment
20th of 131
147 · median 46
Started
2026
with 4 others
Phase 2
70 of 131
14 open now
Primary completion
2027-10
later than 25 of 32 live
Registered
130th of 131
by date
Lead sponsor
5 of 131
Tianjin Medical University Cancer Institute and Hospital

Among the 131 studies testing Albumin-Bound Paclitaxel in Pancreatic Neoplasms, this one is the 20th largest by planned enrollment, is one of 5 that started in 2026, is one of 70 in phase 2, reaches primary completion later than 25 of the 32 other live ones, and was the 130th registered.

Pancreatic Neoplasms

3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,005 are open to participants now.

Browse Pancreatic Neoplasms studies →

Open to participants now

22 of the 131 studies testing Albumin-Bound Paclitaxel in Pancreatic Neoplasms are open now, in 12 countries. Recruiting first, the newest first:

16 more — sign in →

By country, each count listing its studies:

All 22 open studies →

About Albumin-Bound Paclitaxel

Albumin-Bound Paclitaxel: first FDA approval 2005 (ABRAXANE), first EMA approval 2008. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 745 Pancreatic Neoplasms studies recruiting now, 478 (64%) set no upper age limit and 151 (20%) stop at 75 or younger; 40 take children under 18; 59 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Get alerts for this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 131 studies testing Albumin-Bound Paclitaxel in Pancreatic Neoplasms, or all of them as a file.
02

Study summary

This is a prospective, multi-center, multi-cohort exploratory study. Cohort 1 enrolls 39 patients with unresectable locally advanced or metastatic pancreatic cancer, who will receive first-line treatment with cisplatin plus nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine (PAXG).

Cohort 2 enrolls 27 patients with borderline-resectable or high-risk resectable pancreatic cancer, who will receive neoadjuvant therapy with the PAXG regimen.

Cohort 3 enrolls patients with pancreatic cancer who have undergone curative resection, who will receive adjuvant therapy with nab-paclitaxel (Ⅱ), capecitabine, and gemcitabine.

Objectives of Study: To evaluate the efficacy and safety of nab-paclitaxel (Ⅱ)-based regimes for pancreatic cancer.

03

Conditions studied

  • Pancreatic Cancer
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  • Aged 18 to 75 years old.
  • Histopathologically confirmed pancreatic adenocarcinoma meeting any one of the following conditions: (1) Unresectable locally advanced or pancreatic cancer, with no prior systemic anti-tumor therapy for advanced disease. Prior /adjuvant chemotherapy is permitted, provided the interval from completion of prior chemotherapy to study drug administration is more than 6 months. (2) High-risk resectable or borderline resectable pancreatic cancer assessed by a multidisciplinary team.(3) Curative resection (R0 or R1 resection) performed without prior neoadjuvant therapy, and adjuvant treatment can be initiated within 12 weeks postoperatively.
  • Presence of at least one per v1.1 (exclusive to participants in Cohort 3).
  • (ECOG) performance status score of 0 or 1.
  • Estimated survival time ≥ 3 months.
  • Adequate bone marrow function: (ANC) ≥ 1.5×10⁹/L, count (PLT) ≥ 100×10⁹/L, (Hb) ≥ 90 g/L.
  • Adequate liver function: (ALT) and aspartate transaminase (AST) ≤ 2.5× (≤5×ULN allowed in patients with liver metastases); total ≤ 1.5×ULN.
  • Adequate renal function: serum creatinine (Cr) ≤ 1.5×ULN, or ≥ 60 mL/min (calculated by Cockroft-Gault formula).
  • Adequate coagulation function: (PT) and activated partial thromboplastin time (APTT) ≤ 1.5×ULN.
  • Women of must have a negative serum/urine pregnancy test within 14 days prior to enrollment, be non-lactating, and agree to use effective throughout the study and for 6 months after the last study treatment. Male participants must agree to effective contraception during the study and for 6 months after study completion.
  • Able to understand the study information; participant or legal representative voluntarily provides written .

Exclusion criteria

Exclusion Criteria:

  • History of other malignant tumors within the past 5 years
  • Known or intolerance to any study drug or .
  • Confirmed homozygous or compound heterozygous DPYD variants leading to complete dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Presence of any of the following comorbidities: ① Severe or uncontrolled cardiovascular disease: (NYHA) Class II or higher chronic heart failure, uncontrolled hypertension (systolic BP >150 mmHg and/or diastolic BP >90 mmHg despite stable medication), etc. ② Severe respiratory disorders: asthma requiring inhaled/systemic , active , etc. ③ Confirmed neurological diseases (epilepsy, dementia, etc.) or Grade ≥2 peripheral sensory/motor neuropathy. ④ Uncontrolled diabetes mellitus (fasting blood glucose ≥10 mmol/L under stable treatment). ⑤ Severe chronic or active infections requiring ≥1 consecutive week of systemic antibacterial, antifungal or antiviral therapy (including tuberculosis). ⑥ Active infection (HIV antibody positive); untreated active (HBsAg/HBcAg positive with HBV-DNA above institutional ) or active infection (HCV antibody positive with HCV-RNA above institutional upper limit of normal).
  • Untreated active (including symptomatic brain or ). Participants with brain metastases are eligible only if brain lesions are stable on imaging performed ≥4 weeks prior to first study dose, no new neurological symptoms or baseline symptom relapse, and no systemic steroid administration for ≥14 days before study treatment initiation, with no evidence of new or enlarged lesions.
  • Medical history as follows: ① Major abdominal/thoracic surgery within 28 days prior to first study dose, or planned major surgery during the study period (diagnostic puncture and infusion port implantation excluded). ② Severe cardiovascular/cerebrovascular events (myocardial infarction, unstable angina, cerebrovascular accident) within 6 months prior to enrollment; clinically silent lacunar infarcts are permitted.
  • History of deep vein thrombosis or pulmonary embolism within 3 months prior to enrollment.
  • Inability to swallow or untreated malabsorption syndrome.
  • Receipt of any product within 1 month prior to enrollment.
  • Any other condition judged by the investigator to render the participant unsuitable for study participation.
Terms in these criteria, in plain language(27)

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumor. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumor measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumor visible on a scan does not by itself rule you out.

RECIST

The standard rules for measuring tumors on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.

“Measurable disease per RECIST 1.1” usually means at least one tumor 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.

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.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

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.

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.

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.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

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.

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.

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.

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.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

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.

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.

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 authorized 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.

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.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colors or preservatives.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

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.

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.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

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.

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.

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.

Brain metastases

Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).

Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.

Leptomeningeal disease

Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.

Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
147 participants (estimated)

Study arms

  • Experimental
    Chort 1

    Cisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, Treatment will continue until disease progression or intolerable toxicity.

    Drug: Cisplatin · Drug: Albumin-bound Paclitaxel (Ⅱ) · Drug: Capecitabine · Drug: Gemcitabine

  • Experimental
    Chort 2

    Cisplatin + Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q2w, with a maximum of 12 treatment cycles.

    Drug: Cisplatin · Drug: Albumin-bound Paclitaxel (Ⅱ) · Drug: Capecitabine · Drug: Gemcitabine

  • Experimental
    Chort 3

    Albumin-bound Paclitaxel (Ⅱ) + Capecitabine + Gemcitabine, q3w, for a total treatment duration of up to 6 months.

    Drug: Albumin-bound Paclitaxel (Ⅱ) · Drug: Capecitabine · Drug: Gemcitabine

Interventions

06

What researchers measure

Primary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: Time from subject's first study drug administration to first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first, assessed up to 5.5 months.

  2. 1-Year Event-Free Survival Rate (1y-EFS Rate)

    Time frame: 12 months after signing informed consent, until first EFS event or loss to follow-up.

  3. Recommended Phase 2 Dose (RP2D)

    Time frame: After all participants in each dose cohort complete the 21-day DLT observation period.

  4. Disease-Free Survival (DFS)

    Time frame: From informed consent signature to tumor recurrence or all-cause death (whichever occurs first), assessed up to 20 months.

Secondary outcomes

  1. Objective Response Rate (ORR)

    Time frame: Tumor response assessment every 8 weeks (±7 days) after first study drug administration until disease progression, death or end-of-follow-up, assessed up to 5.5 months.

  2. Maximum Tolerated Dose (MTD)

    Time frame: After DLT observation completion and RP2D determination for all dose cohorts, assessed up to 1 months.

  3. R0 Resection Rate

    Time frame: After neoadjuvant therapy completion, at pathological report of surgical specimen, assessed up to 7 months.

  4. Incidence of Adverse Events

    Time frame: From the time of informed consent signature through 30 days after last study drug administration.

  5. Disease Control Rate (DCR)

    Time frame: Tumor response assessment every 8 weeks (±7 days) after first study drug administration until disease progression, death or end-of-follow-up, assessed up to 5.5 months..

  6. Overall Survival (OS)

    Time frame: Time from subject's first study drug administration to death from any cause, assessed up to 40 months.

  7. Dose-Limiting Toxicity (DLT)

    Time frame: After all participants in each dose cohort complete the 21-day DLT observation period.

  8. Event-Free Survival (EFS)

    Time frame: From informed consent signature to first local recurrence, distant metastasis, tumor progression, second malignancy or all-cause death (whichever occurs first), assessed up to 16 months.

  9. Major Pathological Response (MPR) Rate

    Time frame: Upon completion of pathological diagnosis of resected surgical specimen, assessed up to 7 months.

  10. Pathological Complete Response (pCR) Rate

    Time frame: Upon completion of pathological diagnosis of resected surgical specimen, assessed up to 7 months.

  11. Duration of Response (DOR)

    Time frame: Time from first documented CR or PR to subsequent disease progression or death from any cause, whichever occurs first, until end-of-follow-up, assessed up to 6 months.

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Oct 2027, 13 months later.

Of 324 non-industry phase 2 interventional studies under Pancreatic Neoplasms, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 36 and three quarters within 80. This study's planned 13 months is below that.

Counting every sponsor, half of 393 studies reached it within 57 months; a quarter within 35 and three quarters within 80.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2026
First posted
Sep 18, 2026
StartEst.
Sep 30, 2026
Primary completionEst.
Oct 31, 2027
CompletionEst.
Apr 30, 2030
Last update
Sep 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07828756
Responsible party
Sponsor
First posted
Sep 18, 2026
Start date
Sep 30, 2026 (estimated)
Primary completion
Oct 31, 2027 (estimated)
Completion
Apr 30, 2030 (estimated)
Last update
Sep 18, 2026

Study contacts

Jihui Hao
Contact
18622221120@163.com
022-2340123-3077

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

Track this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to track

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: Albumin-Bound Paclitaxel

Start the discussion