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Can an immunotherapy cocktail slow pancreatic cancer? a new trial aims to find out.

NCT ID NCT07733050

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This phase II trial is testing whether adding an immunotherapy drug (serplulimab) and a targeted antibody (bevacizumab) to standard chemotherapy can help people with metastatic pancreatic cancer that has progressed after initial treatment. The study enrolls about 34 adults whose cancer has spread and who have already tried one prior therapy. Researchers are measuring overall survival and tumor response to see if this combination offers a benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
serplulimab, bevacizumab, and chemotherapy (FOLFIRINOX or NALIRIFOX)
What this could lead to
If successful, this combination could offer a new second-line treatment option for people with metastatic pancreatic cancer, potentially improving survival.
What could go wrong
This is an early-phase, single-arm trial with only 34 participants, so results may not be generalizable. The combination also carries risks of serious side effects from immunotherapy and chemotherapy.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Voluntary participation with signed written informed consent, good compliance, and willingness to adhere to follow-up visits. * Age ≥ 18 years, male or female. * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1 and life expectancy ≥ 3 months. * Histologically or cytologically confirmed locally advanced unresectable or metastatic pancreatic adenocarcinoma. * Must have received prior first-line (1L) systemic therapy. Prior neoadjuvant or adjuvant chemotherapy is allowed if the last treatment was administered \> 6 months before disease recurrence/progression. * No prior exposure to irinotecan or oxaliplatin. * At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. * Adequate major organ function, defined as follows: Hematology: Hemoglobin ≥ 90 g/L (no transfusion within 14 days); Absolute Neutrophil Count ≥ 1.5 × 10⁹/L; Platelets ≥ 75 × 10⁹/L. Biochemistry: Total bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 3 × ULN (or ≤ 5 × ULN in the presence of liver metastases); Serum creatinine ≤ 1 × ULN with calculated creatinine clearance \> 50 mL/min (Cockcroft-Gault formula). Coagulation: International Normalized Ratio (INR) and Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN (or within therapeutic range for patients on stable anticoagulation). Thyroid: Normal TSH, or abnormal TSH with normal FT3/FT4 (e.g., controlled hypothyroidism). Cardiac: QTc interval (Fridericia's formula) ≤ 450 ms for males and ≤ 470 ms for females. \- Female participants of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and agree to use effective contraception during the study and for 6 months after the last dose. Male participants with female partners of childbearing potential must agree to use effective contraception during the study and for 6 months after the last dose. Exclusion Criteria: * Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibodies, or any other agents specifically targeting T-cell co-stimulation or immune checkpoint pathways. * Prior treatment with bevacizumab or other anti-angiogenic agents. Radiological evidence of major vascular tumor invasion or high risk of fatal hemorrhage; active gastrointestinal bleeding, persistent bleeding disorders, or coagulopathy. * Radiotherapy (except for palliative reasons), endocrine therapy, chemotherapy, immunotherapy, or molecular targeted therapy within 4 weeks prior to the first dose (bisphosphonates for bone metastases are allowed). * Uncontrolled central nervous system (CNS) metastases (i.e., symptomatic or requiring corticosteroids or mannitol for symptom control). * Clinically significant or uncontrolled cardiac disease within 6 months prior to the first dose, including congestive heart failure, angina pectoris, myocardial infarction, or ventricular arrhythmias. * Persistent toxicities from prior therapy ≥ Grade 1 (per NCI-CTCAE v5.0), including Grade 1 peripheral neuropathy. Exceptions: alopecia or conditions deemed not exclusionary by the investigator (with clear documentation). * Other active malignancy within 5 years prior to the first dose, except for adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ. * Active autoimmune disease requiring systemic treatment within 2 years prior to the first dose. Exceptions: vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy. * History of immediate hypersensitivity reactions, eczema, or asthma not controlled by topical corticosteroids. * History of drug-induced interstitial lung disease (ILD), pneumonitis, obstructive pulmonary disease severely affecting lung function, or symptomatic bronchospasm. * Severe infection (\> CTCAE Grade 2) requiring antibiotic therapy within 14 days prior to the first dose (e.g., severe pneumonia, bacteremia, infectious complications requiring hospitalization). * Receipt of live-attenuated vaccine within 4 weeks prior to the first dose, or planned vaccination during the study period. * Known human immunodeficiency virus (HIV) infection, history of allogeneic organ transplantation, or allogeneic hematopoietic stem cell transplantation. * History of allergy or hypersensitivity to any component or excipient of the investigational drugs. * Any other condition deemed by the investigator to be unsuitable for participation in the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality, 200080, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.