GnP Combined With SHR-1701 and Apatinib as First-Line Treatment for Locally Advanced or Metastatic PDAC
NCT07802184 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45
Last updated 2026-09-03
Summary
The goal of this clinical trial is to evaluate the safety and efficacy of GnP combined with SHR-1701 and Apatinib as first-line treatment in patients with locally advanced or metastatic pancreatic ductal adenocarcinoma.
Conditions
Interventions
- DRUG
-
SHR-1701
SHR-1701 is administered by intravenous infusion at a dose of 30 mg/kg once every 3 weeks (Q3W). The dose may be adjusted to the recommended phase II dose (RP2D) determined during the phase Ib safety run-in phase.
- DRUG
-
Apatinib
Apatinib is administered orally at a dose of 250 mg once daily (QD). The dose may be adjusted to the recommended phase II dose (RP2D) determined during the phase Ib safety run-in phase.
- DRUG
-
Gemcitabine is administered by intravenous infusion at a dose of 1000 mg/m² on days 1 and 8 of each 3-week cycle.
- DRUG
-
Nab-paclitaxel is administered by intravenous infusion at a dose of 125 mg/m² on days 1 and 8 of each 3-week cycle.
Sponsors & Collaborators
-
West China Hospital
lead OTHER
Principal Investigators
-
Dan Cao · Division of Abdominal Tumor, Department of Medical Oncology, Cancer Center and State Key Laboratory of Biological Therapy, West China Hospital, Sichuan University, Chengdu, Sichuan
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-09-10
- Primary Completion
- 2029-01-01
- Completion
- 2029-05-01
Countries
- China
Study Locations
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