NCT06762158Active, not recruiting
NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC
Neoadjuvant Chemoradiotherapy Combined With Sequential Perioperative PD-1 Inhibitor for Locally Advanced Esophageal Squamous Cell Carcinoma
Source: ClinicalTrials.gov · Last updated 7 Jan 2025
Brief summary (registry, in English)
This study aims to examine the efficacy of the combination of neoadjuvant chemoradiotherapy and perioperative PD-1 inhibitor in patients with locally advanced esophageal squamous cell cancer and explore the predictive biomarkers for this regimen.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (estimated)
- First submitted
- 22 Dec 2024
- Start date
- 30 Oct 2024
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06762158
What you commit to
- Study type: Interventional
- Planned participants: 50
- From 30 Oct 2024 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with active infection within 2 weeks before the first use of the study drug
Other illness
- A history of interstitial lung disease or non-infectious pneumonia
- A history of autoimmune diseases or abnormal immune system
- Patients who cannot tolerate chemoradiotherapy or surgery due to severe cardiac, lung dysfunction
- Patients diagnosed with any other malignant tumor within 5 years before enrollment, except for malignant tumors with low risk of recurrence and risk of death, such as fully treated basal cell or squamous cell skin and carcinoma in situ of the cervix;
- Known or suspected allergy or hypersensitivity to monoclonal antibodies, any ingredients of Toripalimab, and the chemotherapeutic drugs nab-paclitaxel or cisplatin
- A history of immunodeficiency，including a positive HIV test result or other acquired or congenital immunodeficiency diseases, a history of organ transplantation or allogeneic bone marrow transplantation
Other
- Women during pregnancy or lactation
- Other situations not suitable for enrollment
Who the study is looking for
- 18-75 years old
- Histologically or cytologically confirmed esophageal squamous cell cancer
- Stage T3-4aN0M0 or TanyN1-3M0 according to the American Joint Committee on Cancer staging manual eighth edition
- Eastern Cooperative Oncology Group performance status of 0 or 1
- he indexes of hematology, biochemistry and organ function meet the following requirements: a. white blood cell count (WBC) ≥ 3.0×109/L；b. neutrophil count (ANC) ≥ 1.5×109/L; c. platelets ≥ 85×109/L; d. hemoglobin ≥ 90g/L; e. total bilirubin ≤ 1.5 ULN; f. ALT ≤ 1.5 ULN; g. creatinine clearance rate \>60 mL/min;
- The cardiopulmonary function needs to meet the following criteria: EF ≥ 55%, VC \> 60%, FEV1 \> 1.2L, FEV1%\> 40%, DLco \> 40%
- Women of childbearing age must undergo a pregnancy test within 7 days before enrollment for treatment, and only those with a negative result can be enrolled
- Voluntarily participating in this study
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radiation Oncology Department, Ren Ji Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.