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.
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…
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