NCT06463834
Recruiting
Phase 2
A Study of Sintilimab Combined With Chemotherapy for Neoadjuvant Treatment of Esophageal Squamous Cell Carcinoma
ConditionsEsophageal Squamous Cell Carcinoma
DrugsSintilimab
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Esophageal Squamous Cell Carcinoma
- Sponsor
- Fujian Cancer Hospital
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Pathological complete response
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Detailed Description
This study was designed as a single arm, phase II trial. Subjects will receive 3 cycles of Sintilimab combined with DCF as neoadjuvant therapy. The primary endpoint is pathologic complete response(pCR).
Investigators
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
Outcomes
Primary Outcomes
Pathological complete response
Time Frame: 4 weeks after surgery
Total tumor regression rate under pathologyPrimary tumor or lymph node surgery specimen pathological examination without residual tumor cell
Secondary Outcomes
- Major pathological response(4 weeks after surgery)
- Incidence rate of adverse events(3-year)
- Disease-free survival period(3-year)
Study Sites (1)
Loading locations...
Similar Trials
Not yet recruiting
Phase 2
A Perioperative Sintilimab and Chemotherapy in Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT06152978Fudan University182
Unknown
Phase 2
Effectiveness of Neoadjuvant Chemotherapy Combined With PD-1 Monoclonal Antibody in the Treatment of Operable Esophageal Squamous Cell CarcinomaEsophageal Squamous Cell CarcinomaNCT05174325The First Affiliated Hospital of Soochow University30
Completed
Phase 2
Sintilimab Plus Chemotherapy Followed by dCRT in Locally Advanced ESCCEsophageal Squamous Cell CarcinomaNCT03985046Fudan University75
Recruiting
Phase 2
A Study to Evaluate the Efficacy and Safety of Sintilimab Plus Apatinib and Chemotherapy in Patients With HER-2 Negative Microsatellite Stability (MSS) Advanced or Metastatic Gastric (GC) or Gastroesophageal Junction (GEJ) CancerGastric CancerChemotherapyImmunotherapyNCT05216237Jiuda Zhao31
Not yet recruiting
Not Applicable
Anlotinib Combined With Chemotherapy for the Treatment of HER2 Negative Advanced Breast CancerHER2-negative Breast CancerNCT05334147The First Affiliated Hospital with Nanjing Medical University315