---
title: The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy
nct_id: NCT05640726
overall_status: UNKNOWN
phase: PHASE2
sponsor: Fujian Cancer Hospital
study_type: INTERVENTIONAL
primary_condition: Rectal Cancer
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05640726.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05640726"
ct_last_update_post_date: 2022-12-07
last_seen_at: "2026-05-12T07:32:51.914Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy

**NCT ID:** [NCT05640726](https://clinicaltrials.gov/study/NCT05640726)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Fujian Cancer Hospital
- **Conditions:** Rectal Cancer
- **Start Date:** 2023-05-01
- **Completion Date:** 2026-05-01
- **CT.gov Last Update:** 2022-12-07

## Brief Summary

To explore the efficacy and safety of radiotherapy followed by PD-1+ standard chemotherapy in the first-line treatment of initial unresectable rectal cancer liver metastases

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of the rectum；
* The clinical stage evaluated by MRI was T3-4 and/or N+ and M1a(only liver metastasis)；
* ECOG PS 0-2；
* CHild Pugh A；
* Estimated survival ≥3 months;
* Women of childbearing age should comply with contraceptive measures if pregnancy test is negative;
* Adequate organ and bone marrow functions, ecg, blood, biochemical and other basic tests are not contraindications of chemotherapy;
* Adherence to scheduled visits, treatment plans, laboratory tests, and other study procedures Willingness and ability.

Exclusion Criteria:

* Pregnant or lactating women;
* No previous antitumor therapy；
* No previous liver local therapy；
* No contraception during the reproductive period;
* patients known to have a history of allergy to any study drug, similar drug or excipient;
* Patients with risk of massive gastrointestinal bleeding or gastrointestinal obstruction;
* Patients with a history of thromboembolism, except those caused by PICC;
* Patients with active infection;
* Other conditions that the investigator determines are not suitable for inclusion in the study.
```

## Arms

- **(SCRT) followed by PD-1+ standard therapy** (EXPERIMENTAL)

## Interventions

- **PD-1** (DRUG) — Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks
- **SCRT** (RADIATION) — Radiotherapy dose: 5×5 Gy
- **Bevacizumab** (DRUG) — Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks
- **Oxaliplatin** (DRUG) — Participants will receive Oxaliplatin，85mg/m2，day1
- **Calcium folinate** (DRUG) — Participants will receive calcium folinate ，400mg/m2，day1
- **5-fluorouracil** (DRUG) — Participants will receive 5-fluorouracil ，400mg/m2，day1

## Primary Outcomes

- **progression free survival** _(time frame: up to 36 months)_ — The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

## Secondary Outcomes

- **objective response rate** _(time frame: every 3 months (up to 36 months）)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05640726.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05640726*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*