SCRT + Chemo Targeted Immuno-neoadjuvant Therapy for High-risk pMMR/MSS RC
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
To explore the efficacy and safety of an intensified treatment regimen consisting of short-course radiotherapy followed by mFOLFOX6 chemotherapy combined with precise targeted therapy (based on RAS/BRAF status: cetuximab for wild-type, bevacizumab for mutant) and a PD-1 monoclonal antibody, compared with short-course radiotherapy followed by mFOLFOX6 chemotherapy alone, in high-risk locally advanced pMMR/MSS rectal adenocarcinoma through a prospective, randomized controlled phase III clinical study, providing high-level evidence-based medical evidence to establish a superior neoadjuvant treatment strategy for this population.
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
204 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov