NCT04807673 Pembrolizumab Plus Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Locally Advanced ESCC (KEYSTONE-002)
| NCT ID | NCT04807673 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Tianjin Medical University Cancer Institute and Hospital |
| Condition | Esophageal Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 342 participants |
| Start Date | 2021-12-01 |
| Primary Completion | 2023-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 342 participants in total. It began in 2021-12-01 with a primary completion date of 2023-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of pembrolizumab plus paclitaxel, cisplatin as neoadjuvant therapy followed by surgery, and pembrolizumab as adjuvant therapy, compared with neoadjuvant chemoradiotherapy and surgery for locally advanced ESCC in multicenter.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04807673 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04807673 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 342 participants.
Is NCT04807673 currently recruiting?
Yes, NCT04807673 is actively recruiting participants. Contact the research team at jianghongjing@tmu.edu.cn for enrollment information.
Where is the NCT04807673 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT04807673 clinical trial?
NCT04807673 is sponsored by Tianjin Medical University Cancer Institute and Hospital. The trial plans to enroll 342 participants.