Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Solid Tumors

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

December 26, 2023

Primary Completion Date

September 30, 2025

Study Completion Date

September 30, 2026

Conditions
Metastatic Malignant Solid NeoplasmRadiotherapyImmune Checkpoint BlockadeResistance to Immunotherapy
Interventions
RADIATION

Intestinal Low Dose Radiotherapy-1Gy

1Gy ILDR will be administered to patients in a single fraction. The radiation treatment volume composes both the jejunum and ileum.

RADIATION

Intestinal Low Dose Radiotherapy-2-3Gy

ILDR will be administered as single fractions within 10 days. The total dose of radiotherapy will be 2-3 Gy in 2-3 fractions. ILDR design is as above.

DRUG

PD-1/PD-L1 Inhibitors

The immunotherapy regimen is the previous ICB therapy regimen or modified by the physician in charge. PD-1/PD-L1 inhibitors will be given 1 day after ILDR at a 3-week interval.

Trial Locations (1)

515031

Cancer Hospital, Shantou University Medical College, Shantou

All Listed Sponsors
lead

Chuangzhen Chen

OTHER

NCT06076135 - Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Solid Tumors | Biotech Hunter | Biotech Hunter