A Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.

Last updated: February 7, 2023
Sponsor: Sun Yat-sen University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT05731336
SYU-2022
  • Ages > 18
  • All Genders

Study Summary

The goal of this prospective observational study is to learn about the treatment decisions in advanced colorectal cancer treated with oxaliplatin and irinotecan. The main questions:1. learn about the efficacy and safety of immunotherapy or targeted drugs or other chemotherapy for patients treated with oxaliplatin and irinotecan(non-retreatment/rechallenge group,NR group). 2. learn about the efficacy and safety of oxaliplatin or irinotecan for patients treated with oxaliplatin and irinotecan (retreatment/rechallenge group, RT/RC group). 3. compare the efficacy and safety of various treatment regimens for patients treated with oxaliplatin and irinotecan. This study will only collect the clinical data of patients, without any intervention, in the treatment services. All participants will be provided written informed consent as per the Declaration of Helsinki principles.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Phologically confirmed colorectal adenocarcinoma
  2. Treated by oxaliplatin and irinotecan and discontinued due to progression orintolerable drug toxicity
  3. ECOG 0-2
  4. Predicted survival more than 3 months
  5. Estimated by investigators that the main organ function is enough good to tolerate thenext treatment plan.
  6. Sign informed consent.
  7. Agree to receive survival follow-up

Exclusion

Exclusion Criteria:

  1. Previously exposed to regorafenib, furoquintinib, TAS-102, PD-1 inhibitors, ortargeted drugs or immunotherapy for HER2 amplification, BRAF V600E mutation, and NTRKgene fusion.
  2. Previously rechallenged or retreated by oxaliplatin or irinotecan after progressionfrom chemotherapy regimens including oxaliplatin and irinotecan.
  3. Participate in another interventional clinical study at the same time, unless in thefollow-up stage of intervention study.
  4. 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.
  5. Disagree to take contraceptive measures during the study treatment period or within 6months after the end of the study treatment period.
  6. Has other primary malignant tumor history, unless non-melanoma skin cancer or lentigomaligna or carcinoma in situ with sufficient treatment and no disease recurrence.
  7. Has the history of allogeneic organ transplantation and allogeneic hematopoietic stemcell transplantation.
  8. Has concomitant diseases that seriously endanger patient safety or affect patientcompletion of the study.
  9. 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
    China

    Active - Recruiting

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