Prospective Cohort Study of Neoadjuvant Therapy With Sintilimab (PD-1 Inhibitor) Combined With Chemotherapy in Resectable ESCC

• Conditions: Resectable Esophageal Squamous Cell Carcinoma
• Interventions: Drug: Sintilimab (PD-1 inhibitor)

• Registration Number: NCT06475196
• Lead Sponsor: Tang-Du Hospital

Brief Summary

This study is an open-label, prospective, cohort clinical study to evaluate the safety and efficacy of different cycles of sintilimab in combination with platinum-containing chemotherapy as preoperative neoadjuvant therapy in patients with resectable esophageal cancer. In the study, all subjects who meet the enrollment criteria will be randomized 1:1:1 to receive sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles (Group A), sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle (Group B), sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles (Group B) as neoadjuvant therapy, and receive radical surgery within 4-6 weeks after the completion of the last neoadjuvant therapy. Whether the subjects need adjuvant therapy and adjuvant treatment regimen after surgery are determined by the investigator, and all subjects need to complete the follow-up plan formulated by the study after surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-20
• Primary Completion: 2024-06-20
• Study First Submitted: 2024-06-20
• Study First Submitted QC: 2024-06-20
• Last Update Submitted: 2024-06-20
• Study First Posted: 2024-06-26
• Last Update Posted: 2024-06-26
• Study Completion: 2025-06-20

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Preoperative gastroscopy showed that the main body of the tumor was located.
2. Patients with potentially resectable esophageal cancer evaluated by preoperative imaging (chest contrast-enhanced CT, head CT or MRI, abdominal B-ultrasound, PET/CT), and the potentially resectable patients refer to the 2018 edition of the Diagnosis and Treatment Standards for Esophageal Cancer formulated by the National Health and Wellness Commission, defined as patients with esophageal cancer stage T2-3, N0/N+, M0 or T4a, N0-1, M0 (8th edition AJCC stage in 2017).
3. Signed informed consent and met all the inclusion criteria of this study. 4）aged 18~75 years old 5）ECOG PS score of 0-1;

Exclusion Criteria

1. prior treatment with immune checkpoint inhibitors, including but not limited to anti-CTLA-4, anti-PD-1 and anti-PD-L1 therapeutic antibodies, and OX-40;
2. .previous systemic therapy;
3. current participation in an interventional clinical trial or receipt of another investigational drug or medical intervention within 4 weeks;
4. presence of active hemoptysis, active diverticulitis, abdominal abscess, gastrointestinal obstruction (or other factors affecting the absorption of oral medications such as inability to swallow, nausea and vomiting, abnormal physiologic function, malabsorption syndrome, etc.) that require clinical intervention
5. the presence of any signs or history of bleeding constitution; the presence of unhealed wounds, ulcers, or fractures in patients who have experienced any bleeding or hemorrhagic event ≥ CTCAE Grade 3 within 4 weeks prior to enrollment; -

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group B	Sintilimab (PD-1 inhibitor)	sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle
Group C	Sintilimab (PD-1 inhibitor)	sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles
Group A	Sintilimab (PD-1 inhibitor)	sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles

Primary Outcome Measures

Name	Time	Method
complete pathologic response (pCR)	3 mouths	no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.

Trial Locations

Locations (1)

Tangdu Hospital of the Fourth Millitary Medical University; 🇨🇳 Xi'an, Shaanxi, China