Low Rectal Cancer Treated With Total Neoadjuvant Therapy Plus Concurrent Tislelizumab Immunotherapy

Recruiting Phase 1 Phase 2 Interventional Study
Rectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Fudan University · Other
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About This Trial
This is an open-label, multi-center, single-arm clinical study. All patients received 4-6 cycles total neoadjuvant therapy plus concurrent tislelizumab immunotherapy, 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. …
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Able to provide written informed consent, understand and comply with the requirements and evaluation schedule 2. ≥18, ≤75 years old 3. Histologically confirmed rectal adenocarcinoma 4. immunohistochemistry confirmed pMMR (positive for MLH1, MSH2, MSH6 and PMS2), or PCR /NGS c…
Contacts

Jianmin Xu, MD

+862164041990

xujmin@aliyun.com

CONTACT

Wenju Chang, MD

13764476150

chang_erich@hotmail.com

CONTACT