Tucidinostat Plus PD-1 Inhibitor and Bevacizumab for Advanced Esophagus Cancer, AEG, Gastric Cancer

Sponsor
Ruihua Xu
Study ID
NCT05163483
Phase
PHASE2
Status
Unknown

Conditions

  • Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction, Gastric Adenocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This Phase II study was designed to assess the efficacy and safety of the combination of PD-1 inhibitor, Tucidinostat (chidamide), a histone deacetylase inhibitor, and bevacizumab in advanced Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction, Gastric adenocarcinoma patients.

Key Dates

First listed
Dec 20, 2021
Start date
Jul 1, 2022
Status verified
Jul 2022
Primary completion
Dec 1, 2023
Completion
Dec 1, 2025

Study Design

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

Arms

  • Experimental: Tucidinostat (chidamide), PD-1 inhibitor （Toripalimab), Bevacizumab
    Tucidinostat (chidamide), 30mg, po., biw, q3w Toripalimab, 240mg, ivgtt., d1, q3w Bevacizumab, 7.5mg/kg, ivgtt., d1, q3w approximately 2 years

Primary Outcome Measure

Objective Response Rate（ORR） [ Time Frame: 2 years ]

Central Contacts