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

NCT06475196 | Enrolling By Invitation

• 1 other identifier: IIT202405-09
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Resectable Esophageal Squamous Cell Carcinoma

Keywords

neoadjuvant therapy; PD-1 inhibitor; resectable esophageal squamous cell carcinoma

Outcome Measures

Primary Outcomes (1)

• complete pathologic response (pCR)

  no residual tumor cells in the surgically resected tumor specimen and all sampled regional lymph nodes after neoadjuvant treatment.

  3 mouths

Study Arms (3)

Group A

sintilimab combined with platinum-containing chemotherapy Q3W for 3 cycles

Drug: Sintilimab (PD-1 inhibitor)

Group B

sintilimab combined with platinum-containing chemotherapy Q3W for 2 cycles + sintilimab for 1 cycle

Drug: Sintilimab (PD-1 inhibitor)

Group C

sintilimab combined with platinum-containing chemotherapy for 1 cycle + sintilimab Q3W for 2 cycles

Drug: Sintilimab (PD-1 inhibitor)

Interventions

Sintilimab (PD-1 inhibitor) DRUG

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.

Group A; Group B; Group C

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Preoperative gastroscopy showed that the main body of the tumor was located.
• 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).

You may not qualify if:

• 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;
• previous systemic therapy;
• current participation in an interventional clinical trial or receipt of another investigational drug or medical intervention within 4 weeks;
• 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
• 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; -

Sponsors & Collaborators

• Tang-Du Hospital: lead

Study Sites (1)

Tangdu Hospital of the Fourth Millitary Medical University

Xi'an, Shaanxi, 710000, China

Location

MeSH Terms

Interventions

sintilimab; Immune Checkpoint Inhibitors

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: June 26, 2024
• Study Start: June 20, 2024
• Primary Completion: June 20, 2024
• Study Completion: June 20, 2025
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

CN (1)