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

Sponsor
Hutchmed
Study ID
NCT06361888
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Metastatic Pancreatic Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine — DRUG
    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
  • Nab-paclitaxel Plus Gemcitabine — DRUG
    Drug: Nab-paclitaxel Plus Gemcitabine 1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
  • Surufatinib with Nab-paclitaxel, and Gemcitabine — DRUG
    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

Study Details

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

Key Dates

Start date
May 8, 2024
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
502 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine
  • Active Comparator: Nab-paclitaxel Plus Gemcitabine
  • Other: Surufatinib with Nab-paclitaxel, and Gemcitabine

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From date of first dose of study drug until withdrawal of consent or death (up to approximately 20 months) ]

Central Contacts

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