Combining Sintilimab with Chemotherapy for Esophageal Cancer Treatment
A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
This study is testing if combining a new drug called sintilimab with chemotherapy can help people with advanced esophageal cancer before surgery.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Fujian Cancer Hospital Government |
| Drugs / interventions | chemotherapy, immunotherapy, sintilimab |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT06463834 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of sintilimab when used alongside chemotherapy (docetaxel, cisplatin, and 5-fluorouracil) as a neoadjuvant treatment for locally advanced esophageal squamous cell carcinoma. It is designed as a single-arm, phase II trial where participants will undergo three cycles of this combined therapy. The primary goal is to assess the pathologic complete response (pCR) rate in patients after treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with locally advanced esophageal squamous cell carcinoma that meets specific staging criteria.
Not a fit: Patients with other active malignancies or those who have received prior anti-tumor therapies for the same condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve treatment outcomes for patients with esophageal squamous cell carcinoma by enhancing tumor response before surgery.
How similar studies have performed: Other studies have shown promising results with similar combinations of immunotherapy and chemotherapy in various cancers, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * ≥18 years old and ≤75 years old * Esophageal squamous cell carcinoma diagnosed biopsy histopathology * The primary tumor is located in the middle of the esophagus and T1b-3N1-3M0 /M1 or T3N0M0 diagnosed by CT/MRI/EUS (AJCC 8th) * At least one measurable lesion * Eastern cooperative oncology group (ECOG) performance status of 0 to 1 * With adequate organs function Exclusion Criteria: * Patients with active malignancy within 5 years other than the tumor studied in this study or a localized tumor that has been cured such as resected basal or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or breast cancer * Patients who have a higher risk of bleeding or perforation due to the tumor's obvious invasion of the adjacent organs (aorta or trachea) of the esophageal lesion, or patients who have formed a fistula * Patients who have received any anti-tumor therapy for the research disease in the past, including radiotherapy, chemotherapy, immunotherapy (including but not limited to interleukin, interferon, thymus hormone) and traditional Chinese medicine therapy
Where this trial is running
Fuzhou, Fujian
- Fujian Cancer Hospital — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: Shuoyan Liu
- Email: shuoyanliu2010@163.com
- Phone: 138 0508 8816
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.