NCT05969171

A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With AG or AG in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer

A Single-center, Prospective, Two Cohort Study of Surufatinib Combined With Gemcitabine and Nab-paclitaxel or Gemcitabine Combined With Nab-paclitaxel in the First-line Treatment of Locally Advanced or Metastatic Pancreatic Cancer

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, prospective, two cohort study to evaluate the efficacy and safety of surufatinib in combination with AG or AG alone in the first-line treatment of patients with locally advanced or metastatic pancreatic cancer. Participants with previously received AG chemotherapy for 2 cycles with no disease progression will be enrolled: Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn; During the treatment period, imaging methods were used to evaluate the tumor status every 6 weeks (±7 days) until disease progression (RECIST 1.1) or death (during the patient's treatment) or toxicity was intolerable or other criteria for termination of study treatment specified in the protocol were met, and the tumor treatment and survival status after disease progression were recorded. Safety observation indicators include: AEs, changes in laboratory values, vital signs, and changes in electrocardiogram.

Conditions

• Pancreatic Cancer Metastatic

Interventions

Type	Name	Description
DRUG	Surufatinib, gemcitabine, nab-paclitaxel	Nab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks for a treatment cycle, did not exceed a maximum of 6 treatment cycles. Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks for a treatment cycle. Surufatinib: 250mg, qd, po, every 3 weeks for a treatment cycle. Surufatinib and gemcitabine was continued until disease progression (PD, RECIST 1.1) or death (while the patient was on treatment) or toxicity became intolerant or other criteria for discontinuation of study therapy were met in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation.
DRUG	Nab-paclitaxel, gemcitabine	Nab-paclitaxel: 125mg/m2 intravenously, d1, 8; every 3 weeks as a treatment cycle, should not exceed a maximum of 6 treatment cycles. Gemcitabine: 1000mg/m2, intravenous infusion greater than 30min, d1, 8, every 3 weeks as a treatment cycle, treatment until toxicity intolerance or disease progression, death, or other criteria for termination of study therapy as specified in the protocol. Allow adjustment of dosage according to protocol requirements, including suspension, lowering of dosage or permanent discontinuation.

Timeline

• Start date: 2023-12-05
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2023-08-01
• Last updated: 2025-07-30

Locations

1 site across 1 country: China