A Prospective Cohort Study of Advanced Colorectal Cancer Treated With Oxaliplatin and Irinotecan.
NCT ID: NCT05731336
Last Updated: 2023-02-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
500 participants
OBSERVATIONAL
2022-05-01
2026-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
c-CetuIRI Versus Ersecond-line Irinotecan s-IRI-CetuIRI
NCT04833036
Neoadjuvant Triplet Chemotherapy Regimen in Patients With Resectable Colorectal Cancer
NCT02688023
Chemotherapy Combined With High-dose Radiotherapy for Low Rectal Cancer Using MR Guided Linear Accelerator
NCT05338866
Cetuximab Plus Irinotecan in Patients With NeoRAS Wild-type Metastatic Colorectal Cancer In Third-line Therapy
NCT05962502
Adjuvant Chemotherapy in Clinical Local Advanced CRC Following Preoperational Therapies and pT0-3N0M0 Diagnosis
NCT03748485
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
NR group (Non-retreatment/rechallenge group)
participants who receive immunotherapy or targeted drugs or other chemotherapy beyond treated with oxaliplatin and irinotecan
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dong sheng Zhang
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SYU-2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.