Can an immunotherapy cocktail slow pancreatic cancer? a new trial aims to find out.
NCT ID NCT07733050
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Metastatic pancreatic ductal adenocarcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
- New drug candidate takes aim at Hard-to-Treat pancreatic cancer
- Can a Two-Drug combo tame Hard-to-Treat pancreatic cancer?
- Can a One-Two punch of radiation and immunotherapy tame pancreatic cancer?
- Smart drug delivers chemo directly to pancreatic cancer cells
- Engineered T-Cells take aim at Hard-to-Treat pancreatic cancer
- Could a stomach drug help fight pancreatic cancer?