NCT06652412 - CGA Guided Ultrafractionated RT and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized CRC | Biotech Hunter

Enrollment

124

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 and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.

OTHER

data prospectively collected

in cohort 2, external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected.

RADIATION

Ultrafractionated Radiotherapy

1Fx every 3 or 4weeks

DRUG

Sintilimab

200 mg q3w

DRUG

Fluorouracil

5-Fluorouracil or capecitabine

DRUG

Raltitrexed

DRUG

Oxaliplatin

DRUG

Irinotecan (CPT-11)

irinotecan

All Listed Sponsors

lead

Fudan University

OTHER