NCT05218889

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

Surufatinib Plus Camrelizumab and AS in First Line Treatment of Advanced Metastatic Pancreatic Cancer: a Prospective, Randomized Controlled Clinical Trial

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Chinese PLA General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

For patients with advanced pancreatic cancer (APC), chemotherapy is still the predominant treatment. The first-line regimens include AG (nab-paclitaxel and gemcitabine) and FOLFIRINOX (5-fluorouracil, leucovorin, irinotecan, and oxaliplatin). AS (nab-paclitaxel and S-1) was explored and widely used in China especially for those with poor performance. This prospective, randomized controlled phase 1b/2 clinical study was designed to explore the efficacy and safety of surufatinib combined with camrelizumab and AS as first-line treatment compared with AG in APC.

Conditions

• Pancreatic Cancer
• PDAC - Pancreatic Ductal Adenocarcinoma
• Pancreas Cancer
• Pancreatic Neoplasms

Interventions

Type	Name	Description
DRUG	surufatinib + camrelizumab + nab-paclitaxel + S-1	phase 1b: surufatinib 200 or 250 mg/d, qd po; camrelizumab: 200mg, I.V., D1, Q3W; nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; S-1: 40mg bid, D1-14, Q3W; DLTs will be evaluated at first cycle; phase 2: surufatinib RP2D + camrelizumab + nab-paclitaxel + S-1 when evaluated SD, PR or CR after 4-6 cycles (according to RECIST 1.1), followed by maintenance treatment: surufatinib + camrelizumab + S-1
DRUG	nab-paclitaxel + gemcitabine	nab-paclitaxel: 125mg/m2, I.V., D1, D8, Q3W; gemcitabine: 1000/m2, ivgtt for more than 30min, D1, D8, Q3W

Timeline

• Start date: 2021-08-04
• Primary completion: 2024-12-16
• Completion: 2025-06-01
• First posted: 2022-02-01
• Last updated: 2024-12-31

Locations

1 site across 1 country: China