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

A Multi-center、Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.

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.

Study Overview

• Status: Recruiting
• Conditions: Advanced Colorectal Cancer

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Dongsheng Zhang, MD., phD.; Phone Number: 86+020-87343795; Email: zhangdsh@sysucc.org.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Sun yat-sen University Cancer Center
      • Contact: Dongsheng Zhang, MD.,phD.; Phone Number: 86+020-87343795; Email: Zhangdsh@sysucc.org.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

1. Phologically confirmed colorectal adenocarcinoma
2. Treated by oxaliplatin and irinotecan and discontinued due to progression or intolerable 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 the next treatment plan.
6. Sign informed consent.
7. Agree to receive survival follow-up

Exclusion Criteria:

1. 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.
2. Previously rechallenged or retreated by oxaliplatin or irinotecan after progression from chemotherapy regimens including oxaliplatin and irinotecan.
3. Participate in another interventional clinical study at the same time, unless in the follow-up stage of intervention study.
4. 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.
5. Disagree to take contraceptive measures during the study treatment period or within 6 months after the end of the study treatment period.
6. 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.
7. Has the history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
8. Has concomitant diseases that seriously endanger patient safety or affect patient completion of the study.
9. Has other problems that is not suitable for clinical research.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate ，ORR	The ORR was defined as the percentage of patients performing a complete response (CR) or a partial response (PR) according to RECIST V1.1.	Up to 12 months
Disease Control Rate，DCR	The ORR was defined as the percentage of patients performing a complete response (CR) or a partial response (PR) or a stable disease (SD) according to RECIST V1.1.	Up to 12 months
Quality of life score	evaluated according to EORTC QLQ-C30 V3.0	Up to 24 months
Comprehensive score of economic burden	evaluated according to COST-PROM	Up to 24 months
Adverse events, AEs	evaluated by NCI-CTC AE V5.0	Up to 24 months

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Anticipated): May 31, 2025
• Study Completion (Anticipated): May 31, 2026

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 7, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 7, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: SYU-2022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No