Evaluating a new treatment combination for metastatic pancreatic cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, randomized, open-label trial aims to assess the efficacy and safety of a combination treatment involving surufatinib, camrelizumab, nab-paclitaxel, and gemcitabine compared to the standard treatment of nab-paclitaxel plus gemcitabine in patients with metastatic pancreatic cancer. Participants will be randomly assigned to receive either the experimental combination or the control treatment as their first-line therapy. The study will include patients aged 18 to 75 with confirmed stage IV pancreatic cancer who have not previously received systemic anti-tumor therapy. The trial will evaluate treatment outcomes based on measurable lesions and overall patient survival.

Why it matters

Who can join: the full rules

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

Where it's running

• Anhui Provincial Hospital
  Hefei, Anhui, China Recruiting
• Beijing Cancer Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking Union Medical College Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University Third Hospital
  Beijing, Beijing Municipality, China Recruiting
• Chongqing General Hospital
  Chongqing, Chongqing Municipality, China Recruiting
• Chongqing University Cancer Hospital
  Chongqing, Chongqing Municipality, China Recruiting

+2 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Shukui Qin — Nanjing Tianyinshan Hospital
• Study coordinator: Panfeng Tan
• Email: panfengt@hutch-med.com
• Phone: +86 21 20671828

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.