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
Hutchmed
502 participants
May 8, 2024
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
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
Drug: Nab-paclitaxel Plus Gemcitabine 1. Nab-paclitaxel: 125 mg/m2, IV drip, D1,D8 2. Gemcitabine : 1000 mg/m2, IV drip, D1, D8
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
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)
View Full Details on ClinicalTrials.gov
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NCT06361888