# A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)

> **NCT07669220** · PHASE2 · RECRUITING · sponsor: **Sixth Affiliated Hospital, Sun Yat-sen University** · enrollment: 76 (estimated)

## Conditions studied

- Rectal Adenocarcinoma
- High-risk Locally Advanced
- Short-course Radiotherapy (SCRT)
- Immunotherapy
- FOLFOX

## Interventions

- **RADIATION:** Short-course Radiotherapy, SCRT
- **DRUG:** Toripalimab

## Key facts

- **NCT ID:** NCT07669220
- **Lead sponsor:** Sixth Affiliated Hospital, Sun Yat-sen University
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2026-01-01
- **Primary completion:** 2028-01-01
- **Final completion:** 2028-01-01
- **Target enrollment:** 76 (ESTIMATED)
- **Last updated:** 2026-06-25

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT07669220

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT07669220, "A Multicenter, Randomized Controlled Phase II Study of Short-Course Radiotherapy Followed by Sequential PD-1 Inhibitor and FOLFOX Chemotherapy Versus Long-Course Chemoradiotherapy for High-Risk Locally Advanced pMMR/MSS Lower Rectal Adenocarcinoma (STAR Trial)". Retrieved via MORVS 2026-10-20 from https://api.morvs.ai/clinical/NCT07669220. Licensed CC0.

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