- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04558684
Radiotherapy With Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer
Short Course Radiotherapy With Total Neoadjuvant Chemotherapy and Immunotherapy in Rectal Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Hubei
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Wuhan, Hubei, China, 430022
- Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who personally provided written consent for participation in the study
- Treatment-naive patients with rectal cancer, in whom the inferior margin of the tumor is at a distance of 10 cm or less from the AV before CRT
- Histologically confirmed adenocarcinoma of rectum (non-metastatic, >T2N0 or low T2N0 rectal cancer) not eligible for up-front organ preservation surgery as deemed by multidisciplinary evaluation
- Patients with the ECOG performance status of 0 or 1 at the time of enrollment
- Women of childbearing potential who consent to practicing contraception during the period from giving informed consent to at least 23 weeks after the last dose of therapy
- Male patients who consent to practicing contraception during the period from giving informed consent to at least 31 weeks after the last dose of the study drug
- Patients must have acceptable organ and marrow function as defined below:
Absolute neutrophil count (ANC) >1,500/uL Hg > 8.0 g/dL; if blood transfusion is performed for achieving adequate hemoglobin level, the level should stay above goal for at least 1 week after transfusion Platelets >100,000/uL Total bilirubin <1.5X normal institutional limits aspartate aminotransferase (AST) (SGOT) / alanine aminotransferase (ALT)(SGPT) < 3X upper limit of normal Creatinine <1.5X upper limit of normal or creatinine clearance (CrCL)>50 by Cockcroft-Gault
Exclusion Criteria:
- Patients with recurrent rectal cancer or a history of pelvic radiation
- Patients with a history of inflammatory bowel disease
- Patients with a history of pneumonitis or interstitial lung disease
- Patients with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease
- Patients requiring treatment with systemic corticosteroids or immunosuppressants or who have received these treatments within 14 days before enrollment in the study
- Patients with a history of thyroid dysfunction
- Patients with a history or finding of cardiovascular risk
- Patients who are positive for any of the following: HIV1 antibody, HIV2 antibody, HTLV1 antibody
- Patients who are pregnant or lactating or who may be pregnant
- Patients with significant unstable mental diseases or other medical diseases that may interfere with the safety of the subjects, obtaining informed consent, or compliance with the procedures for the clinical study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: radiotherapy, chemotherapy and PD1 inhibitor
Treatment will comprise 5 daily fractions of radiotherapy at 5 Gy per fraction followed by chemotherapy and immunotherapy.
Those who achieve a clinical complete response will be considered for organ preservation approach.
All other patients will receive standard surgery.
|
CAPOX (6 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine: Dose of 2000mg/m2,14 days, q3w
Camrelizumab (6 cycles): 200mg on day 1 of each cycle, q3w
Radiotherapy (5 Gy x 5 fractions)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinical complete response rate (cCR)
Time Frame: 8 (+/-4 ) weeks
|
Proportion of patients who achieve a clinical complete response following treatment
|
8 (+/-4 ) weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local regrowth rate
Time Frame: 2 year
|
Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology
|
2 year
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Disease free survival (DFS)
Time Frame: 5 year
|
Five years disease-free survival of this group of patients
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5 year
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Overall survival (OS)
Time Frame: 5 year
|
Fives years overall survival of this group of patients
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5 year
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Incidence of adverse events (AEs)
Time Frame: 1 year
|
Incidence of adverse events will be assessed according to the latest "Clavien- Dindo Classification of surgical complications" and Common Terminology Criteria of Adverse Events (CTCAE).
|
1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Rectal Neoplasms
- Physiological Effects of Drugs
- Immunologic Factors
- Immunomodulating Agents
Other Study ID Numbers
- WUGO-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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