A Clinical Study of Exploring Camrelizumab in the Treatment of Colorectal Mucinous Adenocarcinoma(MAC)
- Sponsor
- Zhejiang Cancer Hospital
- Study ID
- NCT04446091
- Phase
- PHASE1/PHASE2
- Status
- Unknown
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.) — DRUGObserve the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs for colorectal mucinous adenocarcinoma
- Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)+Irinotecan — DRUGObserve the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs and chemotherapy for colorectal mucinous adenocarcinoma
Study Details
This is an open-label, single center, non-randomized, phase Ⅱ trial to evaluate safety and efficacy of using the combination treatment of Camrelizumab with anti-angiogenic drugs and Chemotherapy of metastatic colorectal mucinous adenocarcinoma(MAC).
Key Dates
- Start date
- Jul 1, 2020
- Status verified
- Jun 2020
- Primary completion
- Jul 1, 2021
- Completion
- Jul 1, 2022
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Two-drug groupCamrelizumab:200mg,iv,Q2W; Fruquintinib:5mg,po.qd,Day1\~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1\~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1\~21, repeat every 28 days;
- Experimental: Three-drug groupCamrelizumab:200mg,iv,Q3W; Irinotecan:150mg/m2,iv 30\~90min,d1,Q3W Fruquintinib:5mg,po.qd,Day1\~21, repeat every 28 days;or Regorafenib: 80mg,po.qd,Day1\~21, repeat every 28 days;or Apatinib:250mg,po.qd,Day1\~21, repeat every 28 days;
Primary Outcome Measure
ORR:Objective Response Rate [ Time Frame: through study completion, an average of 2 year ]
Central Contacts
- Luo Cong, Doctor of Oncology13456711894
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