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

HUTCHMED

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine; Drug: Nab-paclitaxel Plus Gemcitabine; Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06361888

2023-012-00CH1

Details and patient eligibility

About

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

Full description

This is 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

Enrollment: 502 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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502 participants in 3 patient groups

Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Experimental group

Treatment:

Drug: Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Nab-paclitaxel Plus Gemcitabine

Active Comparator group

Treatment:

Drug: Nab-paclitaxel Plus Gemcitabine

Surufatinib with Nab-paclitaxel, and Gemcitabine

Other group

Treatment:

Drug: Surufatinib with Nab-paclitaxel, and Gemcitabine