Clinical trial NCT05731336: A Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.
Official title: A Multi-center、Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Advanced Colorectal Cancer
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-02-16
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival, PFS
timeFrame: Up to 12 months
measure: Overall Survival, OS
timeFrame: Up to 24 months
Secondary outcomes:
measure: Objective response rate ，ORR
timeFrame: Up to 12 months
measure: Disease Control Rate，DCR
timeFrame: Up to 12 months
measure: Quality of life score
timeFrame: Up to 24 months
measure: Comprehensive score of economic burden
timeFrame: Up to 24 months
measure: Adverse events, AEs
timeFrame: Up to 24 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
References: