# A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis

Source: https://onco.cc/trials/nct05359393/  
OnCo record `nct05359393` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 2 trial in colorectal cancer, run by Fudan University, not yet recruiting.

## Summary

A Combination Therapy Including Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Distal Metastasis is a phase 2, interventional study registered as NCT05359393 by Fudan University, with a registry enrolment figure of 52 participants, started 2022-12-01 and due to reach its primary completion in 2027-09-01. Interventions recorded: a combination therapy including tislelizumab. Conditions listed: Advanced Rectal Cancer; Liver Metastasis; Pulmonary Metastasis; Microsatellite Stable Colorectal Carcinoma. Primary outcome: NED rate. Colorectal eligibility wording from the registry: "* Initial colonoscopy and pathology: adenocarcinoma;". Sites: China. No results are recorded here; the registry entry is the source.

## Fields

- Kind: Trial
- Status: planned
- Last checked: 2026-09-24
- Also known as: Miracle-1
- Tags: ctgov-ingest; colorectal-deep-dive
- Registry id: NCT05359393
- Phase: 2
- Setting: Radiotherapy Followed by Chemotherapy and Anti-PD-1 Immunotherapy in MSS Rectal Cancer With Resectable Liver/ Pulmonary Metastasis(Miracle-1): A Prospective, Single Arm, Multi-Center, Phase II Clinical Trial
- Sponsor: Fudan University
- Enrolled: 52

## Sources

- ClinicalTrials.gov NCT05359393: https://clinicaltrials.gov/study/NCT05359393

## Connected records

- cancers: [Rectal cancer](https://onco.cc/cancers/rectal-cancer/)
- technologies: [IMRT / IGRT (modern external beam)](https://onco.cc/technologies/imrt-igrt/)
- terms: [Colorectal cancer trials open today (registry snapshot)](https://onco.cc/terms/colorectal-trials-open-today/)

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JSON: https://onco.cc/api/v1/entities/nct05359393.json