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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

NCT05969171 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-07-30

No results posted yet for this study

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Arm 1: Surufatinib plus AG chemotherapy (q3w) until disease progression/death/withdrawn; Arm 2: AG chemotherapy (q3w) until disease progression/death/withdrawn;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

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Principal Investigators

  • Jin Xu · 180 1731 7267

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-05
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05969171 on ClinicalTrials.gov