Combining pembrolizumab with chemotherapy for esophageal cancer treatment
A Multicenter Randomized, Controlled Phase III Clinical Trial of Pembrolizumab Plus Paclitaxel and Cisplatin Versus Neoadjuvant Chemoradiotherapy Followed by Surgery for Locally Advanced Esophageal Squamous Cell Carcinoma (KEYSTONE-002)
This study is testing if combining a drug called pembrolizumab with chemotherapy can help people with advanced esophageal cancer live longer and have better outcomes before surgery compared to standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 342 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, pembrolizumab |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Trial ID | NCT04807673 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with histologically confirmed resectable esophageal squamous cell carcinoma and a performance status of 0 or 1.
Not a fit: Patients with metastatic disease or those who cannot tolerate chemotherapy or immunotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a more tolerable and effective treatment option for patients with locally advanced ESCC.
How similar studies have performed: Other studies have shown promising results with immunotherapy combined with chemotherapy in various cancers, suggesting potential success for this approach in ESCC.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Tianjin, Tianjin Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.