Metastatic Pancreatic Ductal AdenocarcinomaPhase 2NCT07733050
Efficacy and Safety of Serplulimab in Combination With Bevacizumab and FOLFIRINOX or NALIRIFOX as Second-Line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
A Phase 2 study testing Serplulimab and Bevacizumab injection, FOLFIRINOX/NALIRIFOX and S-1 in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Shanghai General Hospital, China at 1 site in China.
Trial summary
This is an investigator-initiated, open-label, single-arm, phase II trial evaluating the efficacy and safety of serplulimab (an anti-PD-1 monoclonal antibody) plus bevacizumab, combined with either FOLFIRINOX or NALIRIFOX chemotherapy, as second-line treatment for metastatic pancreatic ductal adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Ductal Adenocarcinoma
- What is being tested?
- Serplulimab and Bevacizumab injection, FOLFIRINOX/NALIRIFOX and S-1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2026to 1 Aug 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
Shanghai General Hospital Department of Oncology, 021-36126254, shiyilunli@sina.com
About this study
Official title: Efficacy and Safety of Serplulimab in Combination With Bevacizumab and FOLFIRINOX or NALIRIFOX as Second-Line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma: An Open-Label, Single-Arm, Phase II Study
This is an investigator-initiated, open-label, single-arm, phase II trial evaluating the efficacy and safety of serplulimab (an anti-PD-1 monoclonal antibody) plus bevacizumab, combined with either FOLFIRINOX or NALIRIFOX chemotherapy, as second-line treatment for metastatic pancreatic ductal adenocarcinoma. The study will enrol up to 34 patients.
- Being tested
- Serplulimab and Bevacizumab injection, FOLFIRINOX/NALIRIFOX, S-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serplulimab and Bevacizumab injectionDrug
Serplulimab：200 mg, intravenous infusion, Day 1 of each 14-day cycle Bevacizumab：6 mg/kg (second-line) or 5 mg/kg (maintenance), intravenous infusion, Day 1 of each 14-day cycle
FOLFIRINOX/NALIRIFOXDrug
FOLFIRINOX:Oxaliplatin 68 mg/m² IV over 2h, Irinotecan 130 mg/m² IV over 30-90 min, Leucovorin 400 mg/m² IV over 2h, Fluorouracil 400 mg/m² IV bolus then 2400 mg/m² continuous IV over 46h, Day 1, every 14 days NALIRIFOX:Oxaliplatin 60 mg/m² IV over 2h, Liposomal Irinotecan 50 mg/m² IV over 90 min, Leucovorin 400 mg/m² IV over 30 min, Fluorouracil 2400 mg/m² continuous IV over 46h, Day 1, every 14 days
S-1Drug
Oral, dose per local clinical practice, during maintenance phase
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients receive serplulimab 200 mg intravenously (IV) on Day 1 of each 14-day cycle, combined with bevacizumab 6 mg/kg IV on Day 1, plus investigator's choice of either FOLFIRINOX or NALIRIFOX chemotherapy for 8 cycles (16 weeks) as second-line therapy. After the initial 16-week treatment period, patients who achieve disease control (complete response, partial response, or stable disease) based on imaging assessment proceed to maintenance therapy. Maintenance treatment consists of serplulimab 200 mg IV every 2 weeks, bevacizumab 5 mg/kg IV every 2 weeks, and oral S-1 (dose per local clinical practice). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the maximum 2-year serplulimab treatment duration. Receives: Drug: Serplulimab and Bevacizumab injection; Drug: FOLFIRINOX/NALIRIFOX; Drug: S-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Survival (OS)
Overall survival is defined as the time from the date of first study drug administration to the date of death from any cause, assessed by the investigator per RECIST v1.1.
Measured: From date of first dose to date of death from any cause, assessed up to approximately 24 months (or up to the end of study).
Secondary outcomes (4)
Progression-Free Survival (PFS)
Progression-free survival is defined as the time from the date of first study drug administration to the date of first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: From date of first dose to date of first progression or death, assessed up to approximately 24 months.
Objective Response Rate (ORR)
Objective response rate is defined as the proportion of patients achieving a confirmed complete response (CR) or partial response (PR), as assessed by the investigator per RECIST v1.1.
Measured: From baseline to the end of treatment, assessed every 8 weeks during the study, up to approximately 24 months.
Duration of Response (DOR)
Duration of response is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression (per RECIST v1.1) or death from any cause, whichever occurs first.
Measured: From first documented response to progression or death, assessed up to approximately 24 months.
Incidence and Severity of Adverse Events (Safety)
Safety and tolerability assessed by the incidence, severity, and relationship of adverse events (AEs), treatment-emergent AEs (TEAEs), and serious adverse events (SAEs); events leading to dose modification or treatment discontinuation; and changes in vital signs, physical examinations, and clinical laboratory parameters. All AEs will be graded per NCI-CTCAE v5.0.
Measured: From signing of informed consent up to 30 days after the last dose of study treatment (or up to 90 days for SAEs related to serplulimab and irAEs), assessed up to approximately 27 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic Ductal AdenocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai General Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fan Wang, Shanghai General Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07733050
- Sponsor's protocol ID
- HLX10IIT343
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Serplulimab in Combination With Bevacizumab and FOLFIRINOX or NALIRIFOX as Second-Line Therapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma: An Open-Label, Single-Arm, Phase II Study
- ClinicalTrials.gov ID
- NCT07733050
- Acronym / sponsor ID
- HLX10IIT343
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Shanghai General Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Aug 2028 (estimated)
- First posted
- 29 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an investigator-initiated, open-label, single-arm, phase II trial evaluating the efficacy and safety of serplulimab (an anti-PD-1 monoclonal antibody) plus bevacizumab, combined with either FOLFIRINOX or NALIRIFOX chemotherapy, as second-line treatment for metastatic pancreatic ductal adenocarcinoma. The study will enrol up to 34 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Serplulimab and Bevacizumab injection, Drug: FOLFIRINOX/NALIRIFOX, Drug: S-1Patients receive serplulimab 200 mg intravenously (IV) on Day 1 of each 14-day cycle, combined with bevacizumab 6 mg/kg IV on Day 1, plus investigator's choice of either FOLFIRINOX or NALIRIFOX chemotherapy for 8 cycles (16 weeks) as second-line therapy. After the initial 16-week treatment period, patients who achieve disease control (complete response, partial response, or stable disease) based on imaging assessment proceed to maintenance therapy. Maintenance treatment consists of serplulimab 200 mg IV every 2 weeks, bevacizumab 5 mg/kg IV every 2 weeks, and oral S-1 (dose per local clinical practice). Treatment continues until disease progression, unacceptable toxicity, withdrawal of consent, or completion of the maximum 2-year serplulimab treatment duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Serplulimab and Bevacizumab injectionSerplulimab：200 mg, intravenous infusion, Day 1 of each 14-day cycle Bevacizumab：6 mg/kg (second-line) or 5 mg/kg (maintenance), intravenous infusion, Day 1 of each 14-day cycle | Drug | Experimental group |
| FOLFIRINOX/NALIRIFOXFOLFIRINOX:Oxaliplatin 68 mg/m² IV over 2h, Irinotecan 130 mg/m² IV over 30-90 min, Leucovorin 400 mg/m² IV over 2h, Fluorouracil 400 mg/m² IV bolus then 2400 mg/m² continuous IV over 46h, Day 1, every 14 days NALIRIFOX:Oxaliplatin 60 mg/m² IV over 2h, Liposomal Irinotecan 50 mg/m² IV over 90 min, Leucovorin 400 mg/m² IV over 30 min, Fluorouracil 2400 mg/m² continuous IV over 46h, Day 1, every 14 days | Drug | Experimental group |
| S-1Oral, dose per local clinical practice, during maintenance phase | Drug | Experimental group |
Primary outcome
Overall Survival (OS)
Time frame: From date of first dose to date of death from any cause, assessed up to approximately 24 months (or up to the end of study).
Overall survival is defined as the time from the date of first study drug administration to the date of death from any cause, assessed by the investigator per RECIST v1.1.
4 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From date of first dose to date of first progression or death, assessed up to approximately 24 months.
Objective Response Rate (ORR)
Time frame: From baseline to the end of treatment, assessed every 8 weeks during the study, up to approximately 24 months.
Duration of Response (DOR)
Time frame: From first documented response to progression or death, assessed up to approximately 24 months.
Incidence and Severity of Adverse Events (Safety)
Time frame: From signing of informed consent up to 30 days after the last dose of study treatment (or up to 90 days for SAEs related to serplulimab and irAEs), assessed up to approximately 27 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Serplulimab and Bevacizumab injection, FOLFIRINOX/NALIRIFOX and S-1 in people with Metastatic Pancreatic Ductal Adenocarcinoma, run by Shanghai General Hospital, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fan wang (13564260428, fairywong04285@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Survival (OS) (time frame: From date of first dose to date of death from any cause, assessed up to approximately 24 months (or up to the end of study).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.