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Trial Title:
A Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.
NCT ID:
NCT05731336
Condition:
Advanced Colorectal Cancer
Conditions: Official terms:
Colorectal Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
advanced colorectal cancer patients who visit clinic in Sun Yat-sen University Cancer
Center and other cooperative hospitals between May, 2022 and May, 2025
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Sun Yat-sen University Cancer Center
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Dongsheng Zhang, MD.,phD.
Phone:
86+020-87343795
Email:
Zhangdsh@sysucc.org.cn
Start date:
May 1, 2022
Completion date:
May 31, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05731336
