NCT06463834 A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
| NCT ID | NCT06463834 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fujian Cancer Hospital |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2024-03-20 |
| Primary Completion | 2025-03-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2024-03-20 with a primary completion date of 2025-03-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is aimed to evaluate the efficacy and safety of sintilimab combined with chemotherapy (docetaxel+cisplatin+5-fluorouracil, DCF) in neoadjuvant treatment of locally advanced esophageal squamous cell carcinoma.
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06463834 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06463834 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06463834 currently recruiting?
Yes, NCT06463834 is actively recruiting participants. Contact the research team at shuoyanliu2010@163.com for enrollment information.
Where is the NCT06463834 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT06463834 clinical trial?
NCT06463834 is sponsored by Fujian Cancer Hospital. The trial plans to enroll 30 participants.