Intrathecal Combination of Programmed Death-1 (PD-1)/Cytotoxic T-Lymphocyte-Associated Protein 4 (CTLA-4) Bispecific Antibody and Pemetrexed for Leptomeningeal Metastasis

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 7, 2025

Primary Completion Date

January 1, 2026

Study Completion Date

June 1, 2026

Conditions
Leptomeningeal Metastasis
Interventions
DRUG

Cadonilimab (AK104)

Intrathecal injection of PD-1/CTLA-4 bispecific antibody was administered every two weeks for six weeks during the induction phase, followed by monthly injections during the maintenance phase, until recurrence or death.

DRUG

Pemetrexed (Alimta)

Pemetrexed was administrated by intrathecal injection, first as induction therapy, twice per week for 2 weeks, followed by consolidation therapy, once per week for 4 weeks, then maintenance therapy, once per month until the patient's death, leptomeningeal metastasis progresses, or intolerable severe adverse events occurred.

Trial Locations (1)

516000

RECRUITING

The Affiliated Huizhou Hospital, Guangzhou Medical University, Huizhou

All Listed Sponsors
lead

Guangzhou Medical University

OTHER