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

NCT ID: NCT05163483

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 87 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2025-12-01

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.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Tucidinostat (chidamide), PD-1 inhibitor (Toripalimab), Bevacizumab

Intervention Type: DRUG

Tucidinostat (chidamide), 30mg, po., biw, q3w Toripalimab, 240mg, ivgtt., d1, q3w Bevacizumab, 7.5mg/kg, ivgtt., d1, q3w

approximately 2 years

Interventions

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

Intervention Type: DRUG

Other Intervention Names

Tucidinostat (chidamide) JS001

Eligibility Criteria

Inclusion Criteria

1. Age ≥18 years, ≤ 75 years

2. Histologically or cytologically confirmed Esophageal squamous cell cancer, adenocarcinoma of esophagogastric junction and Gastric adenocarcinoma, unresectable, recurrent or metastatic disease.

3. Can provide at least 5 pieces of pathological section or fresh tumor tissue

4. Eastern Collaborative Oncology Group (ECOG) ≤ 1.

5. ≤2 systemic chemotherapy for advanced disease (total number of treatment lines for advanced disease ≤4).

6. 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;

7. Adequate organ function.

8. Life expectancy is more than 3 months.

9. For females of child bearing potential, a negative urine or serum pregnancy test result within 3 days before study treatment.

10. Willing and able to provide written informed consent.

Exclusion Criteria

1. Allergies to any monoclonal antibody or Tucidinostat preparation have been known, and hypersensitivity reactions of more than 3 levels have occurred

2. Previously received immunotherapy and had grade 3 or above immune-related adverse events.

3. Previously received histone deacetylase inhibitors,or toripalimab, or angiogenesis inhibitors.

4. Subjects with any active, known or suspected autoimmune disease or history of autoimmune disease.

5. Known active CNS metastases and/or carcinomatous meningitis.

6. Received a live vaccine within 4 weeks of the first dose of study medication.

7. Major surgery received or severe traumatic injury, fracture, or ulcer occurred within 4 weeks of the first dose of study medication.

8. Pregnant or lactating female.

9. 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.

10. Participate in other clinical trials currently or within 4 weeks prior to enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruihua Xu

OTHER

Sponsor Role: lead

Responsible Party

Ruihua Xu

Sun Yat-sen University cancer center

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ruihua Xu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Sun Yat-sen University

Locations

Cancer center of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

fenghua wang, MD, PhD

Role: CONTACT

wangfeng@sysucc.org.cn

86-2087343795

miaozhen qiu

Role: CONTACT

qiumzh@sysucc.org.cn

86-2087343795

Facility Contacts

Rui-Hua Xu, MD, PhD

Role: primary

Fenghua Wang, MD, PhD

Role: backup

wangfeng@sysucc.org.cn

86-2087343795

Other Identifiers

CSIIT-Q24

Identifier Type: -

Identifier Source: org_study_id