RecruitingPhase 1Phase 2NCT05218889

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

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


Sponsor

Chinese PLA General Hospital

Enrollment

90 participants

Start Date

Aug 4, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — surufatinib (a targeted drug that cuts off blood supply to tumors), camrelizumab (an immunotherapy drug), and chemotherapy (nab-paclitaxel plus gemcitabine) — as a first-line treatment for people with advanced pancreatic cancer that cannot be removed surgically. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced, locally advanced, or metastatic pancreatic ductal adenocarcinoma (the most common type of pancreatic cancer) - You have not yet received any systemic treatment for your advanced disease - You have at least one measurable tumor - You are in good physical condition (ECOG score of 0–1) - Your organ function meets the required levels **You may NOT be eligible if...** - You have previously used VEGFR inhibitors or immunotherapy drugs - You have significant heart disease, uncontrolled high blood pressure, or active bleeding - You have HIV, active hepatitis B or C - You have brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGsurufatinib + 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

DRUGnab-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

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NCT05218889


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