Combining pembrolizumab with chemotherapy for advanced esophageal cancer before surgery

A Single Arm, Single Center, Phase II Clinical Study of Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma

This study is testing if combining pembrolizumab with chemotherapy can help people with advanced esophageal cancer shrink their tumors before surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Tongji University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, pembrolizumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06304350 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of pembrolizumab in combination with albumin paclitaxel and carboplatin as a neoadjuvant therapy for patients with resectable locally advanced esophageal squamous cell carcinoma. Participants will receive two courses of this combination treatment before undergoing surgery, followed by continued pembrolizumab immunotherapy post-surgery. The study aims to evaluate the primary endpoint of pathological complete response (pCR) and major pathological response (MPR) to assess the treatment's efficacy and safety.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with resectable stage II/III esophageal squamous cell carcinoma who have not received prior anti-tumor treatment.

Not a fit: Patients with contraindications for surgery or those who have previously undergone chemotherapy for esophageal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve surgical outcomes and overall survival rates for patients with advanced esophageal cancer.

How similar studies have performed: Previous studies have shown promising results with similar immunotherapy and chemotherapy combinations in treating various cancers, suggesting potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Baseline stage resectable cII/III esophageal squamous cell carcinoma (8th UICC TNM stage);
2. Failure to receive anti-tumor treatment for esophageal squamous cell carcinoma;
3. Age range from 18 to 75 years old;
4. There are no surgical contraindications in the preoperative evaluation of various organ functions;
5. 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;
6. 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;
7. Expected to achieve R0 resection;
8. Physical state ECOG 0-1;
9. The subjects must understand and sign the informed consent form

Exclusion Criteria:

1. Individuals who have received previous treatment for esophageal cancer (surgery, radiotherapy, chemotherapy, immunotherapy, targeted therapy, etc.);
2. Not suitable for surgery or with surgical contraindications;
3. Have a history of other anti PD-L1/PD-1 treatments;
4. 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;
5. Individuals with active autoimmune diseases requiring systemic treatment within 2 years;
6. Patients with poor control of heart disease
7. Pregnant or lactating female patients;
8. 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:

1. The main indicators are missing, and more than half of the items that can be filled in CRF are missing;
2. The surgical procedure violates the plan;
3. Cases that are excluded due to adverse reactions are not evaluated for efficacy, but side effects should be included in the statistics;
4. According to the researcher's opinion, continuing to participate in the study will be harmful to their health;
5. 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;
6. Missing subjects. All subjects who withdrew from the study should record their reasons for withdrawal in the CRF and their medical records. According to the ITT principle, all withdrawn cases should undergo survival analysis and toxicity evaluation for the corresponding group.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai General Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Jiang Fan, MD

Conditions Esophageal Cancer; esophageal cancer；; Pembrolizumab；; Neoadjuvant therapy