A Phase III, Randomized, Clinical Trial of GnP Combined With SBRT and Serplulimab Versus GnP as First-Line Treatment for Patients With Recurrent or Metastatic Pancreatic Cancer (WGOG-PAN 006/ICSBR-2)

NCT07336953 | Not Yet Recruiting Phase 3

• 1 other identifier: WGOG-PAN 006/ICSBR-2
• Study Type: interventional
• Target: 198
• Locations: 0 countries
• Sites: N/A

Brief Summary

This Phase III randomized trial, evaluates whether adding targeted radiation (SBRT) and an immunotherapy drug (Serplulimab) to standard chemotherapy (GnP) can extend the lives of patients with advanced pancreatic cancer.

Conditions

PDAC - Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  From the date of randomization until the date of death from any cause, assessed up to approximately 30 months.

Study Arms (2)

GnP+Serplulimab+SBRT

EXPERIMENTAL

Drug: GnP; Radiation: SBRT; Drug: Serplulimab

GnP

ACTIVE COMPARATOR

Drug: GnP

Interventions

GnP DRUG

The GnP regimen is a standard-of-care chemotherapy consisting of Gemcitabine and nab-Paclitaxel administered in 21-day cycles.

GnP; GnP+Serplulimab+SBRT

SBRT RADIATION

Stereotactic Body Radiotherapy (SBRT) is utilized in the experimental arm as a high-dose local treatment intended to induce immunogenic cell death and synergize with immunotherapy.

GnP+Serplulimab+SBRT

Serplulimab DRUG

Serplulimab is an immunotherapy component used in the experimental arm of this study to enhance the anti-tumor immune response.

GnP+Serplulimab+SBRT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with pathologically confirmed metastatic pancreatic cancer who are inoperable, with diagnosis based on a comprehensive assessment of pathology and imaging studies (CT or MRI);
• Patients who have not previously received any systemic anticancer therapy (including chemotherapy, radiotherapy, or other investigational treatments), or who underwent radical pancreatic cancer resection with standard neoadjuvant or adjuvant chemotherapy and experienced recurrence or progression more than 6 months after the last adjuvant chemotherapy;
• Age 18-75 years, no gender restriction;
• ECOG performance status 0-2;
• At least one measurable tumor lesion: ≥10 mm in longest diameter on spiral CT, ≥15 mm in shortest diameter for lymph nodes; ≥20 mm in maximum diameter on conventional CT or physical examination;
• No more than 10 metastatic lesions throughout the body excluding the primary tumor, with the largest metastatic lesion ≤10 cm in diameter; and at least one lesion deemed suitable for radiotherapy based on imaging assessment;
• Normal major organ function (bone marrow, hepatic, renal, coagulation, etc.):
• Bone marrow function (no transfusion within 14 days prior to screening): WBC ≥3.0×10⁹/L, ANC ≥1.5×10⁹/L, PLT ≥80×10⁹/L, Hb ≥90g/L;
• Liver function: ALT and AST ≤3× upper limit of normal (ULN), TBIL ≤1.5×ULN (if liver metastases present, ALT and AST ≤5×ULN, TBIL ≤2×ULN acceptable for liver-metastatic subjects); Child-Pugh score ≤7 points;
• Renal function: Serum Cr ≤1.5 ULN, proteinuria ≤2+ or ≤2 g/24h, estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73 m² (calculated using Cockcroft-Gault formula);
• Coagulation function: PT, APTT, and INR ≤1.5×ULN. Patients receiving fixed anticoagulant therapy for at least 30 days prior to study drug administration may have PT or INR \>1.5×ULN if deemed suitable for the study by the investigator, provided adequate justification is provided;
• Serum sodium, potassium, calcium, and magnesium levels ≤ Grade 1 (NCI-CTCAE version 5.0);
• Electrocardiogram (ECG) showing QTc interval ≤ 480 ms;
• Expected survival ≥3 months;
• Female subjects of childbearing potential and male subjects with female partners of childbearing potential must use at least one medically acceptable form of contraception (e.g., intrauterine device, oral contraceptives, condoms) during study treatment and for at least 6 months after the last dose of chemotherapy or PD-1 inhibitor;

You may not qualify if:

• Known allergy to any investigational drug;
• Subjects with known or suspected central nervous system (CNS) metastases, i.e., those exhibiting signs or symptoms suggestive of CNS metastases, unless CNS metastases have been ruled out by CT or MRI;
• History of other malignancies within 5 years prior to first administration of the study drug (excluding adequately treated basal cell carcinoma of the skin or cervical carcinoma in situ);
• Prior treatment with any immune checkpoint inhibitor (including anti-PD-1, anti-PD-L1, anti-CTLA-4, etc.);
• Requirement for concomitant antitumor therapy outside the study regimen during the study period, including chemotherapy, targeted therapy, hormonal therapy, other immunotherapy regimens, radiotherapy, or antitumor Chinese herbal medicine;
• Diagnosis of immunodeficiency or ongoing immunosuppressive therapy within 7 days prior to the first study dose;
• Subjects requiring systemic treatment with corticosteroids (\>10 mg/day prednisone equivalent) or other immunosuppressive agents within 14 days prior to the first study drug administration; inhaled or topical steroids are permitted in the absence of active autoimmune disease, and adrenal corticosteroid replacement therapy at a dose ≤10 mg/day prednisone equivalent is allowed;
• Recipients of antitumor vaccines or live vaccines within 4 weeks prior to the first study drug administration;
• Major surgery within 28 days prior to the first study drug administration, defined as surgery requiring at least 3 weeks of postoperative recovery before study treatment initiation. Tumor needle biopsies or lymph node excision biopsies are permitted;
• Requirement for concomitant medications during the trial that may affect the metabolism of the study drug;
• Presence of uncontrollable third-space effusions (e.g., pleural effusion, pericardial effusion, or ascites);
• Concurrent uncontrolled cardiovascular or cerebrovascular clinical symptoms or diseases, including but not limited to: NYHA Class II or higher heart failure, unstable angina, myocardial infarction or cerebral infarction within the past 6 months, clinically significant supraventricular or ventricular arrhythmias that remain uncontrolled despite clinical intervention;
• Uncontrolled hypertension (defined as systolic blood pressure \>160 mmHg and/or diastolic blood pressure \>100 mmHg despite treatment);
• History of severe hemorrhagic or thromboembolic events within the past 6 months, such as cerebrovascular accident (including transient ischemic attack), pulmonary embolism, or spontaneous major bleeding from tumors;
• Severe infection (CTCAE ≥ Grade 2) within 4 weeks prior to first study drug administration, such as severe pneumonia requiring hospitalization, bacteremia, or infection-related complications; baseline chest imaging demonstrating active pulmonary inflammation with clinically relevant symptoms or signs; Symptoms or signs of infection within 2 weeks prior to the first dose of study drug, requiring oral or intravenous antibiotic treatment, except for prophylactic antibiotic use;

Sponsors & Collaborators

• West China Hospital: lead

Central Study Contacts

Dan Cao

CONTACT

medzpei@163.com; medzpei@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief Physician, West China Hospital, Sichuan University

Study Record Dates

• First Submitted: January 4, 2026
• First Posted: January 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share