Neoadjuvant Short-Course Radiotherapy With or Without Chemotherapy and AK112 in Locally Advanced Rectal Cancer
ConditionRectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
Sponsorfan li
About this trial
This phase II multicenter, randomized study evaluates the safety and efficacy of neoadjuvant short-course radiotherapy (SCRT) sequentially combined with AK112 (Envafolimab) with or without chemotherapy in patients with locally advanced rectal cancer (LARC). The study also aims to identify biomarkers predicting tumor response and develop efficacy prediction models.
Eligibility criteria
Qualifiers
Signed written informed consent.
Age 18-80 years, male or female.
Histologically confirmed rectal adenocarcinoma.
Clinical baseline stage T3-4NxM0 or TxN1-2M0 by MRI assessment.
Disqualifiers
Allergy to monoclonal antibodies, AK112 components, or CapeOX regimen.
Previous or current use of immune checkpoint inhibitors or immune-related 3.treatments.
Trial design
Treatments tested in this trial
- AK112 with SCRT and CapeOX
- AK112 with SCRT
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
fan li
Lead sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor institution
Source ClinicalTrials.gov