Combination treatment for advanced esophageal and gastric cancers
Tucidinostat in Combination With PD-1 Inhibitor and Bevacizumab as Late-line Treatment in Patients With Advanced Esophageal Squamous Cell Cancer, Adenocarcinoma of Esophagogastric Junction and Gastric Adenocarcinoma
This study is testing a new combination treatment for people with advanced esophageal and gastric cancers to see if it can help them when their cancer can't be removed or has come back.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 87 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | toripalimab, chemotherapy, immunotherapy, bevacizumab |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05163483 on ClinicalTrials.gov |
What this trial studies
This Phase II study evaluates the safety and efficacy of a combination therapy involving Tucidinostat, a histone deacetylase inhibitor, along with a PD-1 inhibitor and Bevacizumab in patients with advanced esophageal squamous cell cancer, adenocarcinoma of the esophagogastric junction, and gastric adenocarcinoma. The study aims to determine how well this combination works in patients whose cancer is unresectable, recurrent, or metastatic. Participants must provide tumor tissue samples and meet specific health criteria to be eligible for the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with confirmed advanced esophageal or gastric cancers who have limited prior treatments.
Not a fit: Patients with early-stage cancer or those who have received extensive prior treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced esophageal and gastric cancers.
How similar studies have performed: Other studies have shown promise with similar combination therapies in treating advanced cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou, Guangdong
- Cancer center of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Ruihua Xu, MD, PhD — Sun Yat-sen University
- Study coordinator: fenghua wang, MD, PhD
- Email: wangfeng@sysucc.org.cn
- Phone: 86-2087343795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.