Combination of Metronomic Capecitabine With Camrelizumab for Treatment of Refractory Solid Tumor Trial (Cohort 3)

Sponsor
Ruijin Hospital
Study ID
NCT04932187
Phase
PHASE1
Status
Unknown

Conditions

  • Hepatobiliary, Pancreatic and Other Gastrointestinal Carcinoma (Non-stomach, Non-esophagi)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

This is a single center phase 1 trial to observe safety and efficacy of metronomic capecitabine plus PD-L1 antibody camrelizumab to treat hepatobiliary, pancreatic and other gastrointestinal carcinoma (non-stomach, non-esophagi) patients who had disease progression after all standard regimens. This study is one of the cohorts of a multi-cohort trial called Combination of Metronomic capecitabine with Camrelizumab for treatment of refractory solid tumor (McCrest) trial.

Key Dates

Start date
Aug 1, 2021
Status verified
Sep 2021
Primary completion
Jul 1, 2023
Completion
Jul 1, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental
    Capecitabine 500mg bid. po. Camrelizumab 200mg ivgtt. d1 q2w

Primary Outcome Measure

Rate of adverse events as assessed by CTCAE v5.0 [ Time Frame: 48 months ]

Central Contacts