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Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial
This study is designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS (nab-paclitaxel and S-1) as first-line treatment compared with AG (nab-paclitaxel and gemcitabine) in unresectable advanced or metastatic pancreatic cancer.
Details
| Lead sponsor | Chinese PLA General Hospital |
|---|---|
| Phase | Phase 1/Phase 2 |
| Status | RECRUITING |
| Enrolment | 90 |
| Start date | 2021-08-04 |
| Completion | 2025-06 |
Conditions
- Pancreatic Cancer
- PDAC - Pancreatic Ductal Adenocarcinoma
- Pancreas Cancer
- Pancreatic Neoplasms
Interventions
- surufatinib + camrelizumab + nab-paclitaxel + S-1
- nab-paclitaxel + gemcitabine
Primary outcomes
- DLTs — Up to 21 days after the first dose of surufatinib
Dose-limiting toxicities will be evaluated by the investigators at the first cycle in Ib phase - RP2D — Up to 21 days after the first dose of surufatinib
The RP2D is defined as the dose level of surufatinib chosen by the investigators for the phase II experimental arm, based on DLTs - ORR — up to 3 years
The proportion of patients with a confirmed complete response or partial response
Countries
China