NCT04929652

Surufatinib Combine With Immunotherapy and Chemotherapy for Second-line Treatment in Advanced Colorectal Cancer

Surufatinib Combine With Immunotherapy and Chemotherapy for Second-line Treatment in Advanced Colorectal Cancer：An-open ，Single-arm，Multic-centers Ⅰb/Ⅱ Study.

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Jiangsu Cancer Institute & Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The objective is to investigate the efficacy and safety of Surufatinib Combine With Immunotherapy and Chemotherapy for Second-line Treatment in Advanced Colorectal Cancer.

Detailed description

Currently second-line treatment is the Anti-vascular combined chemotherapy, the third line standard is multi-target antivascular therapy, RIGONIVO research in three line treatment of good data, but failed to further validation in the real world, one of the reasons may be the third line therapy, patients physical score is relatively poor, immunotherapy to join may play a role,As we know, the PS score of all effective cases in the Rigonivo study was 0. Therefore, if the idea of antivascular combined immunotherapy is moved forward, it is possible to achieve better efficacy,Based on the above,The objective is to investigate the efficacy and safety of Surufatinib Combine With Immunotherapy and Chemotherapy for Second-line Treatment in Advanced Colorectal Cancer.

Conditions

• Advanced Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Surufatinib,Camrelizumab,Irinotecan,GM-CSF	1. Dose climbing stage design (n=12) : Surufatinib: Oral, 3w.The initial dose of 250mg/ day (n=6) : If 2 out of 6 patients developed \> DLT in the first treatment cycle, the exploratory dose was 200 mg/ day; if ≤2 out of 6 patients developed DLT, the exploratory dose was 300mg/ day (n=6);At the next dose phase, if 2 out of 6 patients with \> developed DLT, the previous dose was recommended or the study was terminated;If no more than 2 out of 6 patients developed DLT, the dose was the recommended dose；PD-1,200mg, iv,D1, 3w；Irinotecan: 200mg/㎡, iv, D1, 3w；GM-CSF,D2, D3, D4, D5, D6 and D7 in the first week of each cycle ； 2. Dose expansion phase design(n=36): 1. Surufatinib: Oral, 3w. the dose was set according to the recommended dose in the dose climbing stage; 2. PD-1(Camrelizumab) : 200mg, iv,D1, 3w; 3. Irinotecan: 200mg/㎡, iv, D1, 3w; 4. GM-CSF: continuous administration of D2, D3, D4, D5, D6 and D7 in the first week of each cycle, 5ug/kg once per body weight, once a day, 3w.

Timeline

• Start date: 2021-06-01
• Primary completion: 2022-06-01
• Completion: 2024-06-01
• First posted: 2021-06-18
• Last updated: 2021-06-18

Locations

5 sites across 1 country: China