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

RECRUITINGPHASE2/PHASE3

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

NCT06361888•Hutchmed

View on ClinicalTrials.gov

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

Eligibility

Age

18 - 75 years

Sex

ALL

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;

Locations (2)

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

May 8, 2024

Primary Completion Date

May 31, 2028

Completion Date

May 31, 2028

Last Updated

December 30, 2025

Enrollment

502

ESTIMATED participants

Conditions

Metastatic Pancreatic Cancer

Interventions

Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

DRUG

Nab-paclitaxel Plus Gemcitabine

DRUG

Surufatinib with Nab-paclitaxel, and Gemcitabine

DRUG

Contacts

Panfeng Tan

CONTACT

+86 21 20671828 panfengt@hutch-med.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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