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

NCT ID: NCT06361888

Last Updated: 2025-12-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 502 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-08
• Study Completion Date: 2028-05-31

Brief 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

Detailed 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

Conditions

Metastatic Pancreatic Cancer

Keywords

First-line treatment in patients

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Group Type: EXPERIMENTAL

Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Intervention Type: 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

Group Type: ACTIVE_COMPARATOR

Nab-paclitaxel Plus Gemcitabine

Intervention Type: 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

Group Type: OTHER

Surufatinib with Nab-paclitaxel, and Gemcitabine

Intervention Type: 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

Interventions

Surufatinib 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

Intervention Type: DRUG

Nab-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

Intervention Type: DRUG

Surufatinib 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

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hutchmed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China

Site Status: NOT_YET_RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Panfeng Tan

Role: CONTACT

Phone: +86 21 20671828

Email: panfengt@hutch-med.com

Facility Contacts

Shukui Qin, Prof.

Role: primary

Jihui Hao, Prof.

Role: primary

Other Identifiers

2023-012-00CH1

Identifier Type: -

Identifier Source: org_study_id