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RECRUITING
NCT05218889
PHASE1/PHASE2

Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

This study is designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS (nab-paclitaxel and S-1) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in unresectable advanced or metastatic pancreatic cancer.

Official title: Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

90

Start Date

2021-08-04

Completion Date

2025-06

Last Updated

2024-12-31

Healthy Volunteers

No

Interventions

DRUG

surufatinib + camrelizumab + nab-paclitaxel + S-1

phase 1b: surufatinib 200 or 250 mg/d, qd po; camrelizumab: 200mg, I.V., D1, Q3W; nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; S-1: 40mg bid, D1-14, Q3W; DLTs will be evaluated at first cycle; phase 2: surufatinib RP2D + camrelizumab + nab-paclitaxel + S-1 when evaluated SD, PR or CR after 4-6 cycles (according to RECIST 1.1), followed by maintenance treatment: surufatinib + camrelizumab + S-1

DRUG

nab-paclitaxel + gemcitabine

nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W

Locations (1)

Chinese PLA General Hospital

Beijing, China