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

Fujian Provincial Cancer Hospital

Status and phase

Not yet enrolling

Phase 2

Conditions

Rectal Cancer

Treatments

Radiation: SCRT

Drug: PD-1

Drug: 5-fluorouracil

Drug: Oxaliplatin

Drug: Bevacizumab

Drug: Calcium folinate

Study type

Interventional

Funder types

Other

Identifiers

NCT05640726

TCO002

Details and patient eligibility

About

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

Enrollment

30 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No 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.