NCT06361888 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 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | Hutchmed |
| Condition | Metastatic Pancreatic Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 502 participants |
| Start Date | 2024-05-08 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 502 participants in total. It began in 2024-05-08 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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 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;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06361888 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Metastatic Pancreatic Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06361888 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06361888 currently recruiting?
Yes, NCT06361888 is actively recruiting participants. Contact the research team at panfengt@hutch-med.com for enrollment information.
Where is the NCT06361888 trial being conducted?
This trial is being conducted at Nanjing, China, Tianjin, China.
Who is sponsoring the NCT06361888 clinical trial?
NCT06361888 is sponsored by Hutchmed. The trial plans to enroll 502 participants.
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