Last updated: February 7, 2023
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Colorectal Cancer
Treatment
N/AClinical Study ID
NCT05731336
SYU-2022
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Phologically confirmed colorectal adenocarcinoma
- Treated by oxaliplatin and irinotecan and discontinued due to progression orintolerable drug toxicity
- ECOG 0-2
- Predicted survival more than 3 months
- Estimated by investigators that the main organ function is enough good to tolerate thenext treatment plan.
- Sign informed consent.
- Agree to receive survival follow-up
Exclusion
Exclusion Criteria:
- Previously exposed to regorafenib, furoquintinib, TAS-102, PD-1 inhibitors, ortargeted drugs or immunotherapy for HER2 amplification, BRAF V600E mutation, and NTRKgene fusion.
- Previously rechallenged or retreated by oxaliplatin or irinotecan after progressionfrom chemotherapy regimens including oxaliplatin and irinotecan.
- Participate in another interventional clinical study at the same time, unless in thefollow-up stage of intervention study.
- Proposed to use a treatment regimen containing regorafenib, furquintinib, andtrifluridine, but has any problems obstacling oral drugs, such as inability toswallow, chronic diarrhea and intestinal obstruction et al.
- Disagree to take contraceptive measures during the study treatment period or within 6months after the end of the study treatment period.
- Has other primary malignant tumor history, unless non-melanoma skin cancer or lentigomaligna or carcinoma in situ with sufficient treatment and no disease recurrence.
- Has the history of allogeneic organ transplantation and allogeneic hematopoietic stemcell transplantation.
- Has concomitant diseases that seriously endanger patient safety or affect patientcompletion of the study.
- Has other problems that is not suitable for clinical research.
Study Design
Total Participants: 500
Study Start date:
May 01, 2022
Estimated Completion Date:
May 31, 2026
Connect with a study center
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
ChinaActive - Recruiting

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