Short-course Radiotherapy Combined With CAPOX and PD-1 Antibody Versus Long-course Chemoradiotherapy Combined With CAPOX for Early Low-lying Rectal Cancer
NCT ID: NCT06462053
Last Updated: 2024-06-17
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
PHASE2
134 participants
INTERVENTIONAL
2024-04-01
2027-03-01
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.
Short-course Radiotherapy Combined With CapeOx and PD-1 Inhibitor After Local Excision for High-risk Early Rectal Cancer (TORCH-LE)
NCT06455124
CAPOX and PD-1 Antibody Combined With or Without Radiotherapy for MSS Locally Advanced Rectal Cancer
NCT06281405
Hypofractionated Radiotherapy Plus Immunotherapy Versus Conventional Radiotherapy in Locally Recurrent Rectal Cancer
NCT06928584
The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer
NCT05628038
Short-course Radiotherapy Combined With Chemotherapy and Pd-1 Inhibitor for Locally Advanced Colon Cancer(TORCH-C)
NCT05732493
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.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Short-course Radiotherapy plus immunochemotherapy group
The patients will receive short-course radiotherapy (25Gy/5Fx, SCRT), followed by 4 cycles of CAPOX and PD-1 antibody, finally receive the TEM or TME surgery or adopt WW option.
Short-course radiotherapy
Short-course radiotherapy: 25Gy/5Fx
PD-1 antibody (Toripalimab)
Toripalimab 240mg d1 q3w
Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Capecitabine
Xeloda
Long-course Radiotherapy plus chemotherapy group
The patients will receive long-course radiotherapy (50Gy/25Fx,LCRT, concurrent capecitabine), followed by 2 cycles of CAPOX, finally receive the TEM or TME surgery or adopt WW option.
Long-course radiotherapy
Long-course radiation: 50Gy/25Fx
Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Capecitabine
Xeloda
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Short-course radiotherapy
Short-course radiotherapy: 25Gy/5Fx
PD-1 antibody (Toripalimab)
Toripalimab 240mg d1 q3w
Long-course radiotherapy
Long-course radiation: 50Gy/25Fx
Oxaliplatin
Oxaliplatin: 130mg/m2 d1 q3w
Capecitabine
Xeloda
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. pathological confirmed adenocarcinoma
3. clinical stage T1-3bN0-1, tumor maximum diameter less than 4cm
4. the distance from anal verge less than 5 cm
5. without distance metastases
6. KPS \>=70
7. with good compliance
8. microsatellite repair status is MSS/pMMR
9. without previous anti-cancer therapy or immunotherapy
10. signed the inform consent
Exclusion Criteria
2. pathological confirmed signet ring cell carcinoma
3. clinical stage T1N0 and can be resected locally
4. history of other malignancies within 5 years
5. serious medical illness, such as severe mental disorders, cardiac disease, uncontrolled infection, etc.
6. immunodeficiency disease or long-term using of immunosuppressive agents
7. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/L, Hb≥90g/L, PLT≥100×10\^9/L, ALT/AST ≤2.5 ULN, Cr≤ 1 ULN
8. DPD deficiency
9. allergic to any component of the therapy
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fudan University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Zhen Zhang
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Zhen Zhang, M.D, PH.D
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Fudan University Shanghai Cancer Center
Shanghai, , 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.
FDRT-2023-377-3496
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.