NCT05357846 PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)
| NCT ID | NCT05357846 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Sun Yat-sen University |
| Condition | Squamous Cell Esophageal Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 422 participants |
| Start Date | 2022-11-01 |
| Primary Completion | 2031-01-01 |
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.
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 422 participants in total. It began in 2022-11-01 with a primary completion date of 2031-01-01.
⚠ 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 primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.
Eligibility Criteria
Inclusion Criteria: 1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable. 2. Patients must not have received any prior anticancer therapy. 3. More than 6 months of expected survival. 4. Age ranges from 18 to 70 years. 5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney. 6. WHO PS score 0-1 7. Signed informed consent document on file. Exclusion Criteria: 1. Patients have received any prior anticancer therapy. 2. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin. 3. Patients with concomitant hemorrhagic disease. 4. Patients who cannot tolerate surgery. 5. Pregnant or breast feeding. 6. Patients without informed consent because of psychological, family, social or any other factors. 7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more. 8. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer. 9. Patients with history of diabetes over 10 years and unsatisfactory glycemic control. 10. Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery. 11. Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation. 12. Patients with history of interstitial lung disease or noninfectious pneumonia. 13. Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment. 14. Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).
Contact & Investigator
HONG YANG
PRINCIPAL INVESTIGATOR
Sun Yat-Sen University Cancer Center
Frequently Asked Questions
Who can join the NCT05357846 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Squamous Cell Esophageal 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 NCT05357846 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 422 participants.
Is NCT05357846 currently recruiting?
Yes, NCT05357846 is actively recruiting participants. Contact the research team at yanghong@sysucc.org.cn for enrollment information.
Where is the NCT05357846 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05357846 clinical trial?
NCT05357846 is sponsored by Sun Yat-sen University. The principal investigator is HONG YANG at Sun Yat-Sen University Cancer Center. The trial plans to enroll 422 participants.