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

Sponsor
Jiangsu Cancer Institute & Hospital
Study ID
NCT04929652
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Advanced Colorectal Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Surufatinib,Camrelizumab,Irinotecan,GM-CSF — DRUG
    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.

Study Details

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

Key Dates

Start date
Jun 1, 2021
Status verified
Jun 2021
Primary completion
Jun 30, 2022
Completion
Jun 30, 2024

Study Design

Enrollment
48 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Advanced CRC
    Patients with Advanced CRC were given Surufatinib Combine With Immunotherapy and Chemotherapy.

Primary Outcome Measure

Maximum Tolerable Dose (MTD) [ Time Frame: up to 12 months ]

Central Contacts

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