CGA Guided Ultrafractionated RT and First-line Systemic Treatment in Elderly or Frail Patients with MCRC

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

110

Participants

Timeline

Start Date

November 30, 2024

Primary Completion Date

November 30, 2027

Study Completion Date

November 30, 2028

Conditions
Colon CancerRectal Cancer
Interventions
DRUG

Ultrafractionated RT and CGA Guided systemic treatment.

in cohort 1, all patients will receive Ultrafractionated RT (1Fx every 3 or 4weeks) and Sintilimab (q3w). Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive Fluorouracil/Raltitrexed, with/without targeted therapy, and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, with/without targeted therapy, and BSC.

RADIATION

Ultrafractionated Radiotherapy

1Fx every 3 or 4weeks

DRUG

PD-1 antibody

Sintilimab

DRUG

Chemotherapy (Fluorouracil)

5-Fluorouracil or capecitabine

DRUG

Chemotherapy (Raltitrexed)

Raltitrexed

DRUG

Chemotherapy (Oxaliplatin)

Oxaliplatin

DRUG

Chemotherapy (CPT-11)

Irinotecan

DRUG

Targeted Therapy (anti-VEGF)

anti-VEGF antibody

DRUG

Targeted Therapy (anti-EGFR)

anti-EGFR antibody

All Listed Sponsors
lead

Fudan University

OTHER

NCT06665087 - CGA Guided Ultrafractionated RT and First-line Systemic Treatment in Elderly or Frail Patients with MCRC | Biotech Hunter | Biotech Hunter