CCRT Followed by PD-1 Inhibitor Maintenance Therapy in Locally Advanced ESCC

NCT06964568 | Recruiting Phase 3

• 1 other identifier: ESO-Shanghai 27
• Study Type: interventional
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if concurrent chemoradiotherapy followed by immunotherapy as maintenance therapy works to treat locally advanced esophageal squamous cell cancer in adults.

Conditions

Radiotherapy; Immunotherapy; Esophageal Carcinoma

Outcome Measures

Primary Outcomes (1)

• PFS

  PFS for all patients with PD-1 inhibitor maintenance therapy vs all patients with surveillance

  2 years

Secondary Outcomes (4)

• PFS

  2 years

• OS

  2 years

• OS

  2 years

• Adverse events

  up to 2 years

Other Outcomes (1)

• biomarker analysis

  2 years

Study Arms (4)

Unlimited RT and PD-1 inhibitor maintenance therapy

EXPERIMENTAL

Unlimited radiotherapy 50.4Gy/28Fx. PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.

Drug: PD-1 inhibitor; Radiation: Unlimited radiotherapy; Drug: TP regimen

Unlimited RT and surveillance

ACTIVE COMPARATOR

Unlimited radiotherapy 50.4Gy/28Fx.

Radiation: Unlimited radiotherapy; Drug: TP regimen

TDLN-sparing RT and PD-1 inhibitor maintenance therapy

EXPERIMENTAL

TDLN-sparing radiotherapy 50.4Gy/28Fx. PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year followed by radiotherapy.

Drug: PD-1 inhibitor; Drug: TP regimen; Radiation: TDLN-sparing radiotherapy

TDLN-sparing RT and surveillance

EXPERIMENTAL

TDLN-sparing radiotherapy 50.4Gy/28Fx.

Drug: TP regimen; Radiation: TDLN-sparing radiotherapy

Interventions

TDLN-sparing radiotherapy RADIATION

Tumor draining lymph nodes-sparing radiotherapy 50.4Gy/28Fx

TDLN-sparing RT and PD-1 inhibitor maintenance therapy; TDLN-sparing RT and surveillance

PD-1 inhibitor DRUG

PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year.

TDLN-sparing RT and PD-1 inhibitor maintenance therapy; Unlimited RT and PD-1 inhibitor maintenance therapy

TP regimen DRUG

Chemotherapy: Paclitaxel 135mg/m2 d1+cisplatin 25mg/m2 d1-3 q28d

TDLN-sparing RT and PD-1 inhibitor maintenance therapy; TDLN-sparing RT and surveillance; Unlimited RT and PD-1 inhibitor maintenance therapy; Unlimited RT and surveillance

Unlimited radiotherapy RADIATION

Unlimited radiotherapy 50.4Gy/28Fx

Unlimited RT and PD-1 inhibitor maintenance therapy; Unlimited RT and surveillance

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Aged 18 years or above
• Histologically confirmed esophageal squamous cell carcinoma
• Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification
• \. Eastern Cooperative Oncology Group(ECOG) performance status: 0-1 8. Life expectancy ≥3 months 9. Adequate organ functions Absolute neutrophil counts (ANC) ≥1.5×109⁄L; Hemoglobin (Hb) ≥9g⁄dl; Platelet (Plt) ≥100×109⁄L; Total bilirubin ≤1.5 upper limit of normal (ULN); Aspartate transaminase (AST) ≤2.5 ULN; Alanine aminotransferase (ALT) ≤2.5 ULN; Creatinine ≤1.5 ULN

You may not qualify if:

• Esophageal perforation or hematemesis
• Any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism and hypothyroidism (effective hormone replacement therapy excepted)) and immunosuppressive agents or systemic hormonal therapy indicated within 28 days (for adverse events of chemoradiotherapy excepted).
• Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.
• Allergic to any of the ingredients in PD-1 inhibitors for injection.
• Uncontrolled heart diseases or clinical symptoms, such as: (1) New York Heart Association(NYHA) class II or higher heart failure; (2) unstable angina; (3) myocardial infarction within 1 year; (4)clinically significant arrhythmia requiring clinical intervention.
• Congenital or acquired immunodeficiency (such as HIV infection); active hepatitis B (HBV-DNA≥104 copy number/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the detection limit of the analytical method); active tuberculosis.
• Active infection or unexplained fever \>38.5 °C within 2 weeks before randomization (fever due to tumor excepted, according to investigator).
• Patients with fertility reluctant to take contraceptive measures during the trial, or female patients pregnant or breastfeeding.
• According to the investigator, other factors that may cause termination of the study. ie, other serious diseases (including mental illness) require combined treatment, family or social factors, which may affect the safety or the collection of trial data.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Immune Checkpoint Inhibitors; TP protocol

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Antineoplastic Agents, Immunological; Antineoplastic Agents; Therapeutic Uses

Central Study Contacts

Kuaile Zhao, MD

CONTACT

+86-21-64175590; kuaile_z@sina.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): February 1, 2031
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

CN (1)