Lvosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer

PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

November 1, 2024

Primary Completion Date

November 1, 2026

Study Completion Date

November 1, 2026

Conditions
CRCMSSMetastatic Cancer
Interventions
DRUG

Ivosidenib (AK112)

Participants will receive Ivosidenib in combination with CapeOX chemotherapy and radiotherapy. Participants will first receive Ivosidenib in combination with CapeOX during the first cycle, followed by radiotherapy starting 2 weeks after medication. Depending on the dose limits of normal tissue radiation, Stereotactic Ablative Radiotherapy (SABR), large fraction radiotherapy, or high-dose combined with low-dose radiotherapy will be administered to primary and metastatic lesions. One week after completing radiotherapy, participants will continue to receive Ivosidenib in combination with CapeOX systemic treatment. If primary and metastatic lesions are too extensive for initial radiotherapy, participants will continue to receive Ivosidenib in combination with CapeOX systemic treatment until the lesions shrink, at which point radiotherapy may be considered.。

Trial Locations (1)

200032

Xinxiang Li, Shanghai

All Listed Sponsors
lead

Fudan University

OTHER

NCT06593548 - Lvosidenib (AK112) Combined With CapeOX and Radiotherapy in Patients With Unresectable Metastatic MSS-type Colorectal Cancer | Biotech Hunter | Biotech Hunter