Combining pembrolizumab with chemotherapy for esophageal cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness and safety of pembrolizumab combined with paclitaxel and cisplatin as a neoadjuvant therapy followed by surgery, compared to traditional neoadjuvant chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma (ESCC). The trial aims to determine if this combination can improve event-free survival rates. It involves multiple centers and includes rigorous eligibility criteria to ensure participant safety and treatment efficacy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Histologically confirmed esophageal squamous cell carcinoma;
2. R0 resectable thoracic esophageal cancer, cT1-3N1-2M0, cT2-3N0M0 (AJCC V8 TNM classification);
3. No suspicious metastatic lymph nodes on the clavicle;
4. Have a performance status of 0 or 1 on the ECOG Performance Scale;
5. Age 18-75 years old, both men and women;
6. Be willing and able to provide written informed consent/assent for the trial;
7. Demonstrate adequate organ function ;
8. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours before receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;
9. Be willing to provide tissue, blood, and urine samples. Tissue should be from a newly obtained core or excisional biopsy of a tumor lesion through repeated biopsies. Newly-obtained is defined as a specimen obtained up to 4 weeks (28 days) before initiation of treatment on Day 1.
10. Have not received systemic or local treatment for esophageal cancer in the past.

Exclusion Criteria:

1. Ineligibility or contraindication for esophagectomy;
2. Prior therapy (operation, radiotherapy, immunotherapy, or chemotherapy) for esophageal cancer
3. Active autoimmune disease or history of autoimmune disease;
4. Requiring systemic treatment with either corticosteroids or other immunosuppressive medications;
5. Subjects with a history of symptomatic interstitial lung disease;
6. History of allergy to study drug components;
7. Women must not be pregnant or breast-feeding;
8. Patient has received prior chemotherapy, radiotherapy, target therapy ，and immune therapy for this malignancy or any other past malignancy;
9. Underlying medical conditions that, in the Investigator's opinion, will make the administration of study drug hazardous or obscure the interpretation of toxicity or adverse events.

Where it's running

• Department of minimally invasive esophageal surgery, Tianjin Medical University Cancer Institute and Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Hongjing Jiang, MD,PhD
• Email: jianghongjing@tmu.edu.cn
• Phone: 18622221069

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Neoadjuvant therapy for resectable esophageal squamous cell carcinoma

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  Recruiting at 3 sites Phase 2 Tang-Du Hospital · Xi'an, Shaanxi and 2 other locations · NCT06006650

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.