# Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study

Source: https://onco.cc/trials/nct06390982/  
OnCo record `nct06390982` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial of tislelizumab, capecitabine and fOLFOX (5-FU, leucovorin, oxaliplatin) in colorectal cancer, run by Fudan University, not yet recruiting.

## Summary

Organ Preservation With Tislelizumab and Total Neoadjuvant Therapy in Patients With Low Rectal Cancer: RELIEVE -01 Study is a phase 2, interventional study registered as NCT06390982 by Fudan University, with a registry enrolment figure of 46 participants, started 2024-05 and due to reach its primary completion in 2025-12. Interventions recorded: Radiotherapy; Tislelizumab; Capecitabine; Oxaliplatin; Capecitabine. Conditions listed: RECTAL NEOPLASMS; Rectal Cancer. Primary outcome: Complete Response rate (CR rate). Colorectal eligibility wording from the registry: "Histologically confirmed rectal adenocarcinoma". No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT06390982
- Phase: 2
- Setting: A Single-arm, Multicenter, Phase II Clinical Study of Chemoradiotherapy Followed by Tislelizumab Combined With Chemotherapy for Organ Preservation in Resectable Low Rectal Cancer：the RELIEVE-01 Study
- Sponsor: Fudan University
- Enrolled: 46

## Sources

- ClinicalTrials.gov NCT06390982: https://clinicaltrials.gov/study/NCT06390982

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [Cytotoxic chemotherapy](https://onco.cc/technologies/cytotoxic-chemotherapy/), [Immune checkpoint inhibitors](https://onco.cc/technologies/checkpoint-inhibitor/), [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/), [Platinum agents](https://onco.cc/technologies/platinum/)
- drugs: [Capecitabine](https://onco.cc/drugs/capecitabine/), [FOLFOX (5-FU, leucovorin, oxaliplatin)](https://onco.cc/drugs/folfox/), [Tislelizumab](https://onco.cc/drugs/tislelizumab/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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