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

Inclusion Criteria8

  • Fully understand and voluntarily sign an informed consent form, willing and able to follow the study process;
  • Age range is 18-75 years old (inclusive);
  • Pancreatic cancer confirmed by histology or cytology;
  • Stage IV metastasis Pancreatic cancer patients;
  • Have not received previous systematic first line anti-tumor treatment in the stage of metastatic pancreatic cancer;
  • According to RECIST 1.1, there is at least one measurable lesion;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1;
  • Expected survival time ≥ 12 weeks;

Exclusion Criteria10

  • Use of systematic anti-tumor therapy within 2weeks prior to the first dose;
  • Presence of other malignancies in the past 5 years;
  • Received major surgical surgery within 60 days before the first dose;
  • Have received any surgery or invasive treatment within 4 weeks before the first use of the drug;
  • Received palliative radiotherapy within 1 week before the first dose; received radical radiotherapy within 4 weeks before the first dose;
  • Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, or gemcitabine;
  • Received inducers or inhibitors of cytochrome P450 (CYP) 3A within 2 weeks or 5 half-lives (whichever is longer) before the first dose;
  • Use of immunosuppressive drugs within 4 weeks before first dose;
  • Known history of clinically significant liver disease, including active viral hepatitis infection or other active hepatitis or clinically significant moderate to severe cirrhosis;
  • Patients who currently have hypertension that cannot be controlled by medication;

Interventions

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

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


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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