Tucidinostat Plus PD-1 Inhibitor and Bevacizumab for Advanced Esophagus Cancer, AEG, Gastric Cancer
Phase 2
Recruiting
- Conditions
- Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction, Gastric Adenocarcinoma
- Interventions
- Registration Number
- NCT05163483
- Lead Sponsor
- Ruihua Xu
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 87
Inclusion Criteria
- Age ≥18 years, ≤ 75 years
- Histologically or cytologically confirmed Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction and Gastric adenocarcinoma, unresectable, recurrent or metastatic disease.
- Can provide at least 5 pieces of pathological section or fresh tumor tissue
- Eastern Collaborative Oncology Group (ECOG) ≤ 1.
- ≤2 systemic chemotherapy for advanced disease (total number of treatment lines for advanced disease ≤4).
- Patients who have previously used PD-1 antibodies, PD-L1 antibodies, PD-L2 antibodies, or CTLA-4 antibodies (or any other antibodies acting on T cell co-stimulation or checkpoint pathways) or require a duration of ≥16 weeks;
- Adequate organ function.
- Life expectancy is more than 3 months.
- For females of child bearing potential, a negative urine or serum pregnancy test result within 3 days before study treatment.
- Willing and able to provide written informed consent.
Exclusion Criteria
- Allergies to any monoclonal antibody or Tucidinostat preparation have been known, and hypersensitivity reactions of more than 3 levels have occurred
- Previously received immunotherapy and had grade 3 or above immune-related adverse events.
- Previously received histone deacetylase inhibitors,or toripalimab, or angiogenesis inhibitors.
- Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.
- Known active CNS metastases and/or carcinomatous meningitis.
- Received a live vaccine within 4 weeks of the first dose of study medication.
- Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.
- Pregnant or lactating female.
- Uncontrolled clinically significant systemic diseases, including active infection, unstable angina, angina occurred within 3 months,≥ NYHA II congestive heart failure, myocardial infarction occurred within 6 months, severe arrhythmia, liver, kidney, or metabolic disease.
- Participate in other clinical trials currently or within 4 weeks prior to enrollment.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Tucidinostat (chidamide), PD-1 inhibitor （Toripalimab), Bevacizumab 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 Measures
Name Time Method Objective Response Rate（ORR） 2 years Objective Response Rate（ORR）by RECIST 1.1,the total proportion of patients with complete response（CR）, partial response（PR）
- Secondary Outcome Measures
Name Time Method Progression-free survival(PFS) 2 years Time from treatment until disease progression or death
Disease Control Rate （DCR） 2 years the total proportion of patients with complete response（CR）, partial response（PR）and stable disease（SD）
Duration of Response（DoR） 2 years Time from the achievement of a response to progression
Overall survival(OS) 3 years Time from treatment until death from any cause
Trial Locations
- Locations (1)
Cancer center of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China