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Recruiting Phase 1, Phase 2 NCT05218889

Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer

Trial Parameters

Condition Pancreatic Cancer
Sponsor Chinese PLA General Hospital
Study Type INTERVENTIONAL
Phase Phase 1, Phase 2
Enrollment 90
Sex ALL
Min Age 18 Years
Max Age 75 Years
Start Date 2021-08-04
Completion 2024-12-16
Interventions
surufatinib + camrelizumab + nab-paclitaxel + S-1nab-paclitaxel + gemcitabine

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: 1. Have fully understood this study and voluntarily signed the informed consent form; 2. Patients with histologically or cytologically confirmed unresectable, locally advanced, or metastatic pancreatic ductal adenocarcinoma; 3. Age 18-75 years old (inclusive); 4. No prior systemic therapy for advanced pancreatic carcinoma; 5. ECOG PS 0-1; 6. Must have at least one measurable lesion, with the longest diameter of at least 10 mm as measured by spiral CT scan, or at least 20 mm as measured by conventional CT scan (according to Response Evaluation Criteria in Solid Tumors, i.e. RECIST v1.1); 7. Expected survival ≥ 3 months; 8. The functions of vital organs meet the following requirements (the use of any blood components and cell growth factors within \*14 days before enrollment is not allowed): Absolute neutrophil count ≥1.5×109/L; Platelets ≥100×109/L; Haemoglobin ≥90 g/L; Total bilirubin \< 1.5 × ULN; ALT and/or AST \< 1.5 × ULN ( \< 3 × ULN for patients with metastase

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