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A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS) | Clinical Trials | Clareo Health

RECRUITINGPHASE2

A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)

NCT06709417•Shanghai Chest Hospital

View on ClinicalTrials.gov

Summary

This is a prospective, single-arm, phase II clinical study designed to evaluate the efficacy and safety of sintilimab combined with chemotherapy, followed by sequential concurrent chemoradiotherapy as conversion therapy, in treatment-naïve esophageal squamous cell carcinoma (ESCC) patients with cT4bN-/+M0 and/or cTanyN+M0 staging (including those with extracapsular invasion of mediastinal lymph nodes).

Eligibility

Age

20 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed written informed consent prior to the initiation of any study-related procedures.
•2. Age: ≥20 years and ≤75 years, no gender restrictions.
•3. Diagnosed with esophageal squamous cell carcinoma (ESCC) based on histopathology and imaging, with clinical staging of cT4bN-/+M0 and/or cTanyN+M0 (extracapsular invasion of mediastinal lymph nodes).
•4. Thoracic segment esophageal squamous cell carcinoma.
•5. Primary lesion is inoperable or inoperable due to extracapsular invasion of mediastinal lymph nodes.
•6. ECOG performance status (PS) of 0-1.
•7. Estimated survival time ≥6 months.
•8. No prior antitumor therapy for esophageal cancer, including but not limited to chemotherapy, radiotherapy, targeted therapy, or immunotherapy.
•9. At least one measurable lesion as per RECIST 1.1 criteria.
•10. No surgical contraindications based on preoperative evaluation of organ function.
+3 more criteria

Exclusion Criteria

•1. Diagnosis of malignancies other than esophageal cancer within 5 years prior to the first dose of the investigational drug (excluding radically treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the lung, or T1a non-invasive adenocarcinoma).
•2. Patients with existing or high-risk tracheoesophageal or aortoesophageal fistulas.
•3. Presence of distant metastases.
•4. Current participation in an interventional clinical study or receipt of other investigational drugs or devices within 4 weeks prior to the first dose.
•5. Prior treatment with anti-PD-1, anti-PD-L1, or any other agents targeting stimulatory or co-inhibitory T-cell receptors (e.g., CTLA-4, OX-40, CD137).
•6. Receipt of systemic antitumor traditional Chinese medicine or immunomodulatory drugs (including thymosin, interferon, or interleukin) within 2 weeks prior to the first dose, except for local use to control pleural effusion.
•7. Active autoimmune disease requiring systemic therapy (e.g., disease-modifying agents, corticosteroids, or immunosuppressive drugs) within 2 years prior to the first dose, excluding replacement therapy (e.g., thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency).
•8. Use of systemic corticosteroids (excluding nasal, inhaled, or other locally administered corticosteroids) or other immunosuppressive drugs within 7 days prior to the first dose, except for physiological doses of corticosteroids (≤10 mg/day prednisone or equivalent).
•9. History of allogeneic organ transplantation (excluding corneal transplantation) or allogeneic hematopoietic stem cell transplantation.
•10. Known hypersensitivity to active ingredients or excipients in the investigational product.
+21 more criteria

Locations (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

November 1, 2024

Primary Completion Date

December 31, 2027

Completion Date

December 31, 2028

Last Updated

November 29, 2024

Enrollment

ESTIMATED participants

Conditions

Esophageal Squamous Cell Carcinoma (ESCC)

Interventions

Sintilimab

DRUG

Chemotherapy

DRUG

radiotherapy

RADIATION

Contacts

Jun Liu

CONTACT

+862122200000 drjunliu@qq.com

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Esophageal Squamous Cell Carcinoma (ESCC)Esophageal Cancer, Squamous Cell

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

A Phase II Clinical Study of Sintilimab Combined with Chemotherapy Followed by Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma (ESCC) (NICE-CS)

Inclusion Criteria

Exclusion Criteria

MR-Guided Radiotherapy Dose Escalation Trial for Esophageal Squamous Cell Carcinoma

A Study to Investigate the Safety, Pharmacokinetics, and Clinical Activity of AP203 in Patients with Locally Advanced or Metastatic Solid Tumors, and Expansion to Selected Malignancies

Tumor Regression Grade As Predictor of Adjuvant Therapy

Immunochemotherapy ± Salvage Chemoradiation for Local Recurrence of Esophageal Squamous Cell Carcinoma After Definitive Chemoradiotherapy

Intestinal Low-Dose Radiotherapy Plus Immunochemotherapy for Conversion of Borderline Resectable/Unresectable Esophageal Squamous Cell Carcinoma

NCRT Combined With Sequential Perioperative PD-1 Inhibitor for LAESCC