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

NCT04929652 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2021-06-18

No results posted yet for this study

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.

Conditions

  • Advanced Colorectal Cancer

Interventions

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.

Sponsors & Collaborators

  • Jiangsu Cancer Institute & Hospital

    lead OTHER

Principal Investigators

  • Liangjun Zhu · Jiangsu Cancer Institute & Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-06-30
Completion
2024-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04929652 on ClinicalTrials.gov