Evaluating a new treatment combination for 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
This study is testing a new combination of treatments for people with advanced pancreatic cancer to see if it works better than the standard care they usually receive.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 502 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Hutchmed Industry-sponsored |
| Drugs / interventions | camrelizumab, surufatinib |
| Locations | 2 sites (Nanjing, Jiangsu and 1 other locations) |
| Trial ID | NCT06361888 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with confirmed stage IV metastatic pancreatic cancer who have not received prior systemic treatment.
Not a fit: Patients with other malignancies, recent major surgeries, or those who have received prior anti-tumor therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective first-line therapy option for patients with metastatic pancreatic cancer.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in combining targeted therapies with chemotherapy in treating pancreatic cancer.
Eligibility criteria
Show full inclusion / exclusion 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;
Where this trial is running
Nanjing, Jiangsu and 1 other locations
- Nanjing Tianyinshan Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
- Tianjin Cancer Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
Study contacts
- Study coordinator: Panfeng Tan
- Email: panfengt@hutch-med.com
- Phone: +86 21 20671828
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.