The First-line Treatment of RCLM With RAS Mutation Was Local Short-course Radiotherapy (SCRT) + PD-1+ Standard Therapy

Status

Not yet recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05640726

Enrollment

Registered

2022-12-07

Start date

2023-05-01

Completion date

2026-05-01

Last updated

2022-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

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

Interventions

DRUGPD-1

Participants will receive Tislelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks

RADIATIONSCRT

Radiotherapy dose: 5×5 Gy

DRUGBevacizumab

Participants will receive bevacizumab，5mg/kg，intravenously over 60 - 90 minutes, day 1 of every 2 weeks

DRUGOxaliplatin

Participants will receive Oxaliplatin，85mg/m2，day1

DRUGCalcium folinate

Participants will receive calcium folinate ，400mg/m2，day1

DRUG5-fluorouracil

Participants will receive 5-fluorouracil ，400mg/m2，day1

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
progression free survival	up to 36 months	The length of time from enrollment until the time of progression of disease (PFS, progression-free survival).

Secondary

Measure	Time frame	Description
objective response rate	every 3 months (up to 36 months）	Clinical response of treatment according to RESIST v1.1 criteria (ORR, objective response rate).

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026