NCT06304350 Pembrolizumab Combined With Preoperative Chemotherapy (Albumin Paclitaxel+Carboplatin) Neoadjuvant Therapy for Resectable Locally Advanced (Stage II/III) Esophageal Squamous Cell Carcinoma
| NCT ID | NCT06304350 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Tongji University |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 25 participants |
| Start Date | 2024-02-17 |
| Primary Completion | 2026-02-25 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 25 participants in total. It began in 2024-02-17 with a primary completion date of 2026-02-25.
⚠ 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
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
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06304350 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Esophageal Cancer. 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 NCT06304350 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06304350 currently recruiting?
Yes, NCT06304350 is actively recruiting participants. Contact the research team at fan_jiang@tongji.edu.cn for enrollment information.
Where is the NCT06304350 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06304350 clinical trial?
NCT06304350 is sponsored by Tongji University. The trial plans to enroll 25 participants.
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