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

Last updated: September 8, 2025
Sponsor: Hutchmed
Overall Status: Active - Recruiting

Phase

2/3

Condition

Digestive System Neoplasms

Metastatic Cancer

Treatment

Surufatinib with Nab-paclitaxel, and Gemcitabine

Surufatinib Combined With Camrelizumab, Nab-paclitaxel, and Gemcitabine

Nab-paclitaxel Plus Gemcitabine

Clinical Study ID

NCT06361888
2023-012-00CH1
  • Ages 18-75
  • All Genders

Study Summary

To evaluate the efficacy of Surufatnib combined withcamrelizumab, nab-paclitaxel, and gemcitabine versus nab-paclitaxel plus gemcitabine as the first-line treatment in metastatic pancreatic cancer

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Fully understand and voluntarily sign an informed consent form, willing and able tofollow 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 anti-tumor treatment in the stage ofmetastatic 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

Exclusion Criteria:

  1. Use of systematic anti-tumor therapy within 4 weeks prior to the first dose;

  2. Presence of other malignancies in the past 3 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 useof the drug;

  5. Received palliative radiotherapy within 1 week before the first dose; receivedradical radiotherapy within 4 weeks before the first dose;

  6. Any known allergy to surufatinib or its components, camrelizumab, nab-paclitaxel, orgemcitabine;

  7. Received inducers or inhibitors of cytochrome P450 (CYP) 3A and CYP2C8 within 2weeks 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 viralhepatitis infection or other active hepatitis or clinically significant moderate tosevere cirrhosis;

  10. Patients who currently have hypertension that cannot be controlled by medication;

Study Design

Total Participants: 552
Treatment Group(s): 3
Primary Treatment: Surufatinib with Nab-paclitaxel, and Gemcitabine
Phase: 2/3
Study Start date:
May 08, 2024
Estimated Completion Date:
August 31, 2027

Study 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

Connect with a study center

  • Nanjing Tianyinshan Hospital

    Nanjing, Jiang Su 210000
    China

    Site Not Available

  • Nanjing Tianyinshan Hospital

    Nanjing 1799962, Jiangsu 1806260 210000
    China

    Site Not Available

  • Tianjin Cancer Hospital

    Tianjin, Tianjin 300000
    China

    Site Not Available

  • Tianjin Cancer Hospital

    Tianjin 1792947, Tianjin Municipality 1792943 300000
    China

    Active - Recruiting

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