Total Neoadjuvant Treatment ±Immunotherapy for High Risk Locally Advanced Rectal Cancer (TNTi)

Recruiting Phase 3 Interventional Study
Rectal Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. 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 3
Study type
Interventional
Purpose
Treatment
Participants needed
472 (estimated)
Sponsor
Peking University Cancer Hospital & Institute · Other
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About This Trial
The goal of this clinical trial is to compare the PCR rate between Total Neoadjuvant Treatment ±Immunotherapy in high risk locally advanced rectal cancer. The main questions it aims to answer are: * The PCR rate between the two groups * The 3years DFS between the two groups * Chemoradiotherapy and immunotherapy toxicity * Postoperative complications Participants will receive total neoadjuvant tre…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. \>18,\<75 years old 2. ECOG score 0-1 3. colorectal adenocarcinoma confirmed by pathology 4. The distance between the lower margin of the tumor and the anal margin is ≤12cm or the distance between the anorectal ring (ARJ) is ≤8cm 5. The initial local MRI stage was T4b, or mrN…
Contacts

WU AI WEN, M.D.

+8613911577190

wuaw@sina.com

CONTACT

DONG QIU SHI

+8618600172425

dongqiushi1024@163.com

CONTACT