RecruitingPhase 2Phase 3NCT06361888

A Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine in Metastatic Pancreatic Cancer

A Multicenter, Randomized, Open-label, Active-controlled, Phase II/III Trial to Evaluate the Efficacy and Safety of Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine Versus Nab-paclitaxel Plus Gemcitabine as the First-line Treatment in Metastatic Pancreatic Cancer


Sponsor

Hutchmed

Enrollment

502 participants

Start Date

May 8, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

To evaluate the efficacy of surufatinib combined with camrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This Phase II/III trial is testing a four-drug combination — surufatinib (a targeted anti-tumor drug), camrelizumab (immunotherapy), nab-paclitaxel (chemotherapy), and gemcitabine (chemotherapy) — as a first-line treatment for metastatic pancreatic cancer, which is one of the hardest cancers to treat. **You may be eligible if...** - You are 18–75 years old - You have pancreatic cancer confirmed by biopsy and it has spread to other organs (Stage IV / metastatic) - You have not yet received any treatment for your metastatic pancreatic cancer - You have at least one measurable lesion - You are in good general health (ECOG 0–1) - Your expected survival is at least 12 weeks **You may NOT be eligible if...** - You have received anti-tumor therapy within the past 2 weeks - You have another active cancer in the past 5 years - You have had major surgery within the last 60 days - You have active autoimmune disease or are on immunosuppressive medications - 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 Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Camrelizumab: 200mg, IV drip, Q3W, D1 3. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 4. Gemcitabine : 1000 mg/m2, IV drip, D1, D8

DRUGNab-paclitaxel Plus Gemcitabine

Drug: Nab-paclitaxel Plus Gemcitabine 1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8

DRUGSurufatinib with Nab-paclitaxel, and Gemcitabine

Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine 1. Surufatinib: 200mg, qd 2. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 3. Gemcitabine : 1000 mg/m2, IV drip, D1, D8


Locations(2)

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06361888


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