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

NCT05731336 | Recruiting

• 1 other identifier: SYU-2022
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Progression free survival, PFS

  PFS was calculated as the time from the date of treatment initiation to the date of disease progression or the last follow-up

  Up to 12 months

• Overall Survival, OS

  OS was calculated as the time from the date of treatment initiation to the date of any cause of death, or the last follow-up.

  Up to 24 months

Secondary Outcomes (5)

• Objective response rate ，ORR

  Up to 12 months

• Disease Control Rate，DCR

  Up to 12 months

• Quality of life score

  Up to 24 months

• Comprehensive score of economic burden

  Up to 24 months

• Adverse events, AEs

  Up to 24 months

Study Arms (3)

NR group (Non-retreatment/rechallenge group)

participants who receive immunotherapy or targeted drugs or other chemotherapy beyond treated with oxaliplatin and irinotecan

RT group (Retreatment group)

participants retreated oxaliplatin or irinotecan who were treated with oxaliplatin and irinotecan and progressed after 3 months of oxaliplatin or irinotecan discontinuation.

RC group (Rechallenge group)

participants rechallenging oxaliplatin or irinotecan who were treated with oxaliplatin and irinotecan and progressed within 3 months of oxaliplatin or irinotecan discontinuation.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

advanced colorectal cancer patients who visit clinic in Sun Yat-sen University Cancer Center and other cooperative hospitals between May, 2022 and May, 2025

You may qualify if:

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

You may not qualify if:

• Previously exposed to regorafenib, furoquintinib, TAS-102, PD-1 inhibitors, or targeted drugs or immunotherapy for HER2 amplification, BRAF V600E mutation, and NTRK gene fusion.
• Previously rechallenged or retreated by oxaliplatin or irinotecan after progression from chemotherapy regimens including oxaliplatin and irinotecan.
• Participate in another interventional clinical study at the same time, unless in the follow-up stage of intervention study.
• Proposed to use a treatment regimen containing regorafenib, furquintinib, and trifluridine, but has any problems obstacling oral drugs, such as inability to swallow, chronic diarrhea and intestinal obstruction et al.
• Disagree to take contraceptive measures during the study treatment period or within 6 months after the end of the study treatment period.
• Has other primary malignant tumor history, unless non-melanoma skin cancer or lentigo maligna or carcinoma in situ with sufficient treatment and no disease recurrence.
• Has the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
• Has concomitant diseases that seriously endanger patient safety or affect patient completion of the study.
• Has other problems that is not suitable for clinical research.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Central Study Contacts

Dongsheng Zhang, MD., phD.

CONTACT

86+020-87343795; zhangdsh@sysucc.org.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: May 1, 2022
• Primary Completion: May 31, 2025
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

CN (1)