NCT06385730 Neoadjuvant PD-1 Blockade for Elderly Esophageal Squamous Cell Carcinoma (BLESS)
| NCT ID | NCT06385730 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Shanghai Chest Hospital |
| Condition | Esophageal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-06-17 |
| Primary Completion | 2025-05 |
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 60 participants in total. It began in 2024-06-17 with a primary completion date of 2025-05.
⚠ 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 investigators will conduct a prospective phase 2 study to evaluate the efficacy and safety of neoadjuvant PD-1 blockade monotherapy with toripalimab in elderly patients with locally advanced resectable esophageal squamous cell carcinoma (ESCC).
Eligibility Criteria
Inclusion Criteria: 1. Subjects signed the informed consent and volunteered to participate in the study. 2. Esophageal squamous cell carcinoma confirmed by histology or cytology. 3. Thoracic esophageal squamous cell carcinoma confirmed by CT or pet-CT, which is classified as T1N1-3M0 or T2-3N0-3M0 (M1 lymph node metastasis confined to the supraclavicular lymph nodes) (AJCC 8th). 4. Expect to have R0 resection 5. In age \>75. 6. ECOG PS: 0\~1. 7. Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc. 8. No contraindications to surgery. 9. Has sufficient organ function including (1) Blood routine: NE≥1.5×109/L; PLT≥100×109/L; HGB≥90 g/L (2)Comprehensive Metabolic Panel: bilirubin≤ 1.5×ULN; ALT≤2.5×ULN; AST≤2.5×ULN; sCr≤1.5×ULN or CrCl≥50 mL/min（Cocheroft-Gault) (3) Coagulation function: INR≤1.5. 10. Women of childbearing age must undergo a serological pregnancy test within 72 hrs before first administration. Women of childbearing age, or male subjects with childbearing age female partners, must take contraceptive measures from the first dose to five months after last administration. 11. Good compliance, willing to comply with follow-up schedules. Exclusion Criteria: 1.Subjects have received or are receiving any of: 1. anti-tumor interventions such as radiotherapy, chemotherapy, immunotherapy or other medictions. 2. Received systemic corticosteroid therapy (prednisone equivalence\> 10mg/d) or other immunosuppressive agents within the first 2 weeks prior to the first administration. 3. live vaccine within 4 weeks before the first administration. 2\. Cancer related exclusion criteria 1. other cancers instead of ESCC 2. non-recetable or metastatic ESCC 3. not comply with T1N1-3M0 or T2-3N0-3M0 (AJCC 8th). 4. Subjects with other malignant tumors within 5 years before the first administration, but subjects with cervical carcinoma in situ, skin basal cell carcinoma, skin squamous cell carcinoma, and localized prostate cancer received radical surgery in situ that have received radical treatment and do not need other treatment can be included). 3\. Other criteria Subjects have uncontrolled cardiovascular diseases, such as 1) heart failure ≥ NYHA class 2, 2) unstable angina 3) myocardial infarction within 1 year; 4) supraventricular or ventricular arrthymia that needs treatment Subjects with any known active autoimmune disease Pregnant or breastfeeding female Presence of allergy or hypersensitivity to investigational medications HIV positive or active hepatitis B (HbsAg positive and HBV-DNA ≥2000 IU/ml or ≥ 104 copies/mL) or active hepatitis C (HCV antibody positive) or active tuberculosis Investigators assessed there might be other factors that cause subjects to withdrawl.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06385730 clinical trial?
This trial is open to participants of all sexes, aged 76 Years or older, 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 NCT06385730 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 NCT06385730 currently recruiting?
Yes, NCT06385730 is actively recruiting participants. Contact the research team at zhigang.li@shsmu.edu.cn for enrollment information.
Where is the NCT06385730 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06385730 clinical trial?
NCT06385730 is sponsored by Shanghai Chest Hospital. The trial plans to enroll 60 participants.
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