SCRT+mFOLFOX6+PD-1 Antibody and Targeted Therapy for High-Risk pMMR/MSS Rectal Cancer(CRIT)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
To explore the efficacy and safety of short-course radiotherapy combined with mFOLFOX6, PD-1 monoclonal antibody and cetuximab (for RAS/BRAF Wild-Type)/bevacizumab (for RAS/BRAF Mutant) in High-Risk pMMR/MSS Rectal Adenocarcinoma through a prospective study, providing high-level evidence-based medical evidence for the use in the treatment of high-risk rectal cancer.
Eligibility criteria
Qualifiers
Before conducting procedures related to the research protocol but not part of routine care, written informed consent, voluntarily signed and dated by the subject, must be obtained in accordance with regulations and institutional guidelines.
Age 18-75 years.
Histologically or cytologically confirmed pMMR/MSS rectal adenocarcinoma; all other histological types are excluded.
Distance from the lower margin of the rectal tumor to the anal verge ≤10 cm.
Disqualifiers
Patients with a history of severe drug allergies (including allergies to platinum agents, 5-FU, LV, and 5-HT3 receptor antagonists);
Patients who have participated in or are currently participating in other clinical trials within 4 weeks prior to enrollment;
A history of having received anti-PD-1, PD-L1, PD-L2, CTLA-4, or any other specific T-cell costimulatory or checkpoint pathway-targeted therapy;
Severe electrolyte abnormalities;
Trial design
Treatments tested in this trial
- Short-Course Radiotherapy
- PD-1 monoclonal antibody
- mFOLFOX6 regimen
- Cetuximab
- Bevacizumab
- Surgical resection
Treatment groups
49 Participants
are divided into 1 treatment groupLocations
1Sixth Affiliated Hospital, Sun Yat-sen University510065, GuangzhouGuangdong, China
Sponsors and collaborators
Sixth Affiliated Hospital, Sun Yat-sen University
Lead sponsor
Source ClinicalTrials.gov