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

NCT ID: NCT06964568

Last Updated: 2026-02-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 452 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2031-02-28

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

Esophageal Carcinoma; Radiotherapy; Immunotherapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CCRT and PD-1 inhibitor maintenance therapy

Radiotherapy: 50.4Gy/28Fx. Chemotherapy: Paclitaxel 135mg/m2 d1+cisplatin 25mg/m2 d1-3 q28d

PD-1 inhibitors will be administered intravenously, a fixed dose of 200 mg, once every 3 weeks for 1 year within 42 days after the end of radiotherapy

Group Type: EXPERIMENTAL

PD-1 inhibitor

Intervention Type: DRUG

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

Radiotherapy

Intervention Type: RADIATION

Radiotherapy 50.4Gy/28Fx

TP regimen

Intervention Type: DRUG

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

CCRT and surveillance

Radiotherapy: 50.4Gy/28Fx. Chemotherapy: Paclitaxel 135mg/m2 d1+cisplatin 25mg/m2 d1-3 q28d

Group Type: ACTIVE_COMPARATOR

Radiotherapy

Intervention Type: RADIATION

Radiotherapy 50.4Gy/28Fx

TP regimen

Intervention Type: DRUG

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

Interventions

PD-1 inhibitor

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

Intervention Type: DRUG

Radiotherapy

Radiotherapy 50.4Gy/28Fx

Intervention Type: RADIATION

TP regimen

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Written informed consent

2. Aged 18 years or above

3. Histologically confirmed esophageal squamous cell carcinoma

4. Clinical stages T3-4N0M0 or TxN+M0 or TxNxM1 (Only for supraclavicular lymph nodes) based on the 8th UICC-TNM classification

7. 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

Exclusion Criteria

1. Esophageal perforation or hematemesis

2. 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).

3. Previously received or receiving PD-1 antibody therapy or other immunotherapy against PD-1/PD-L1.

4. Allergic to any of the ingredients in PD-1 inhibitors for injection.

5. 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.

6. 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.

7. 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.

8. 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Kuai Le Zhao, MD

Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Kuaile Zhao, MD

Role: CONTACT

kuaile_z@sina.com

+86-21-64175590

Facility Contacts

Kuaile Zhao

Role: primary

kuaile_z@sina.com

+86-21-64175590

Other Identifiers

ESO-Shanghai 27

Identifier Type: -

Identifier Source: org_study_id