Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

NCT06304350 | Recruiting Phase 2 DMC

• 1 other identifier: SGHDOT-24-20
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a prospective, single center, open label, single arm clinical study. Select resectable locally advanced (cT3-4aN0M0, cT1-3N1-2M0, cII/III stage) esophageal cancer with pathological diagnosis of squamous cell carcinoma for inclusion, receive pembrolizumab combined with platinum containing dual drug (albumin paclitaxel+carboplatin) treatment for 2 courses, and undergo surgery. After surgery, continue pembrolizumab immunotherapy. Using pCR as the main endpoint of the study

Conditions

Esophageal Cancer

Keywords

esophageal cancer；; Pembrolizumab；; Neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Pathological complete remission (pCR)

  Defined as the absence of any residual esophageal squamous cell carcinoma cells, including the primary lesion and lymph nodes

  in two weeks after the surgical resection

Secondary Outcomes (5)

• Major pathological remission (MPR)

  in two weeks after the surgical resection

• R0 resection rate

  in two weeks after the surgical resection

• Progression free survival (PFS)

  receiving therapy，up to approximately 2years.

• Total survival time (OS)

  The time from the patient's randomization receiving therapy to death from any cause，up to approximately 2years

• Safety (incidence of adverse drug reactions)

  Randomly group patients to receive treatment for up to two years

Study Arms (1)

Combination of pembrolizumab and platinum containing dual drugs

EXPERIMENTAL

After 2 courses of treatment with pembrolizumab combined with platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed, and postoperative pembrolizumab immunomaintenance therapy continued

Drug: Combination of pembrolizumab and platinum containing dual drugs

Interventions

Combination of pembrolizumab and platinum containing dual drugs DRUG

After 2 courses of treatment with a combination of pembrolizumab and platinum containing dual drugs (albumin paclitaxel+carboplatin), surgery was performed and pembrolizumab immunomaintenance therapy continued after surgery

Combination of pembrolizumab and platinum containing dual drugs

Eligibility Criteria

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

You may qualify if:

• Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);
• Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;
• Age range from 18 to 75 years old;
• There are no surgical contraindications in the preoperative evaluation of various organ functions;
• The following laboratory tests confirm that the bone marrow, liver and kidney functions meet the requirements for participating in the study: hemoglobin ≥ 9.0g/L; White blood cell count 4.0-10 × 109/L; Neutrophil absolute value (ANC) ≥ 1.5 × 109/L; Platelet count ≥ 100 × 109/L; Total bilirubin ≤ 1.5 times the upper limit of normal value; ALT and AST ≤ 2.5 times the upper limit of normal values; The international standardized ratio of prothrombin time is ≤ 1.5 times the upper limit of normal values, and some prothrombin time is within the normal range; Creatinine ≤ 1.5 times the upper limit of normal value;
• Patients who have not undergone chemotherapy, radiation therapy, or hormone therapy for malignant tumors, have no history of other malignant tumors, and do not include prostate cancer patients who have received hormone therapy and have obtained DFS for more than 5 years;
• Expected to achieve R0 resection;
• Physical state ECOG 0-1;
• The subjects must understand and sign the informed consent form

You may not qualify if:

• Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);
• Not suitable for surgery or with surgical contraindications;
• Have a history of other anti PD-L1/PD-1 treatments;
• Individuals with immunodeficiency or long-term systemic steroid therapy, or those who have received any immunosuppressive therapy within 7 days prior to receiving the study drug;
• Individuals with active autoimmune diseases requiring systemic treatment within 2 years;
• Patients with poor control of heart disease
• Pregnant or lactating female patients;
• For patients with drug allergies in the protocol.
• Exit criteria：
• Withdrawal cases refer to subjects who have stopped continuing treatment in clinical research due to various reasons. Subjects who experience the following situations will withdraw from the investigational treatment:
• The main indicators are missing, and more than half of the items that can be filled in CRF are missing;
• The surgical procedure violates the plan;
• Cases that are excluded due to adverse reactions are not evaluated for efficacy, but side effects should be included in the statistics;
• According to the researcher's opinion, continuing to participate in the study will be harmful to their health;
• Patients who fail to undergo non-surgical treatment due to various reasons, including malignant tumor progression, underlying disease progression, patient or their trustee requesting withdrawal, will be reported together;

Sponsors & Collaborators

• Tongji University: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Jiang Fan, MD

CONTACT

15901013210; fan_jiang@tongji.edu.cn

Fu Yang, DM

CONTACT

18101839885

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Department of Thoracic Surgery

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: March 12, 2024
• Study Start: February 17, 2024
• Primary Completion: February 25, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 13, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)