About this trial
This is an open-label, multi-center, single-arm clinical study. All patients received concurrent chemoradiation therapy (CRT) followed by 4 cycles of tislelizumab combined with CAPOX, then underwent clinical response assessment. Patients who achieved CR (cCR+ pCR confirmed by local resection of ncCR) continue tislelizumab combined with CAPOX for another 4 cycles and tislelizumab for 9 cycles, then Watch and Wait. Patients who did not achieved CR underwent total mesorectal excision (TME).
Eligibility criteria
Qualifiers
Able to provide written informed consent, understand and comply with the requirements and evaluation schedule
≥18, ≤75 years old
Histologically confirmed rectal adenocarcinoma
immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS confirmed MSI-L or MSS
Disqualifiers
Histologically confirmed poorly differentiated/undifferentiated adenocarcinoma, mucinous adenocarcinoma and signet ring cell carcinoma
Have received any treatments for rectal cancer, or evidence of distant metastasis
Presence of following high risk factors assessed by MRI: MRF +, EMVI+, cN2, Positive lateral lymph nodes, T3d
Presence or in high risk of obstruction, perforation or bleeding;
Trial design
Treatments tested in this trial
- Radiotherapy
- Tislelizumab
- Capecitabine
- Oxaliplatin
- Capecitabine
Treatment groups
Locations
Sponsors and collaborators
Fudan University
Lead sponsor
Shanghai Zhongshan Hospital
Sponsor institution
Shanghai Zhongshan Hospital
Collaborator
Shanghai Changzheng Hospital
Collaborator
Huadong Hospital
Collaborator
RenJi Hospital
Collaborator
Hebei Medical University Fourth Hospital
Collaborator
First Hospital of China Medical University
Collaborator
Liaoning Cancer Hospital & Institute
Collaborator