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Efficacy and Safety of Cadonilimab and Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma | Clinical Trials | Clareo Health

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Efficacy and Safety of Cadonilimab and Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma

Efficacy and Safety of Cadonilimab Combined with Chemoradiotherapy in Unresectable Locally Advanced Esophageal Squamous Cell Carcinoma-A Single-arm Exploratory Study

NCT06715501•First Affiliated Hospital of Ningbo University

View on ClinicalTrials.gov

Summary

This study is a single center, prospective, single arm exploratory clinical trial aimed at evaluating the efficacy and safety of sequential chemoradiotherapy combined with cetuximab in unresectable locally advanced esophageal squamous cell carcinoma. Patients with advanced unresectable esophageal squamous cell carcinoma who meet the criteria, after signing the informed consent form, will first receive induction therapy with cetuximab combined with paclitaxel and carboplatin chemotherapy for 2 cycles. Within 3 weeks after the second dose, RECIST v1.1 will be used for clinical tumor imaging evaluation, and if necessary, gastroscopy biopsy will be performed. Patients without progression will further receive synchronous radiotherapy and chemotherapy. PTV-C accepts 50.4Gy, 28 times; Radiotherapy combined with paclitaxel and carboplatin weekly regimen. Within three months after completion, conduct safety assessments and preliminary evaluations of tumor response every three weeks. Consolidate treatment with cetuximab until 1 year or intolerance or disease progression occurs.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Clinical diagnosis of locally advanced esophageal squamous cell carcinoma (TN+M0 or T2-3NxM0) by histological examination and/or cytological examination；
•TNM clinical stage II-IIIB that cannot be surgically resected ;
•ECOG score 0-1 points;
•Expected survival ≥ 6 months;
•Without anti-tumor treatment in the past (including but not limited to surgery, radiotherapy, chemotherapy, anti vascular therapy, immunotherapy, etc.);
•Pathological specimens available;
•At least one measurable target lesion or pathological enlargement of lymph nodes with a single lymph node CT scan short diameter ≥ 15mm (according to the efficacy evaluation criteria for solid tumors RECIST 1.1) ;
•The main organ functions well and meets the following standards:
•1. Blood routine examination (without blood transfusion or correction with hematopoietic stimulating factor drugs within 14 days): hemoglobin (Hb) ≥ 90 g/L; Absolute neutrophil count (ANC) ≥ 1.5 × 109/L; Platelet count (PLT) ≥ 80 × 109/L;
•2. Biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; Serum total bilirubin (TBIL) ≤ 1.5 × ULN (Gilbert syndrome subjects, ≤ 3 × ULN); Serum creatinine (Cr) ≤ 1.5 × ULN, or creatinine clearance rate ≥ 60mL/min;
+2 more criteria

Exclusion Criteria

•Other malignant tumors within 5 years prior to the start of this study;
•High risk of gastrointestinal bleeding, esophageal fistula or perforation;
•Unrelieved toxic reactions of grade ≥ 1(excluding alopecia and fatigue; hematological toxicity must be recovered to grade ≤1 or baseline before enrollment);
•Weight loss of ≥20% within 90 days prior to signing the informed consent form;
•Poor nutritional status or a PG-SGA score of ≥9;
•Any severe and/or uncontrolled diseases. This includes:
•1. Uncontrolled blood pressure (systolic pressure ≥150mmHg or diastolic pressure ≥100mmHg);
•2. Suffering from grade ≥2 myocardial ischemia or myocardial infarction, arrhythmia (QTc ≥470ms), and grade ≥2 congestive heart failure (New York Heart Association \[NYHA\] classification);
•3. History of interstitial lung disease, non-infectious pneumonia, pulmonary fibrosis, or other uncontrolled acute pulmonary diseases;
•4. Active or uncontrolled severe infections (grade ≥2 CTCAE infections);
+22 more criteria

Locations (1)

First Affiliated Hospital of Ningbo University

Ningbo, Zhejiang, China

Key Dates

Start Date

December 1, 2024

Primary Completion Date

September 1, 2025

Completion Date

September 1, 2027

Last Updated

March 25, 2025

Enrollment

ESTIMATED participants

Conditions

Locally Advanced Esophageal Squamous Cell CarcinomaII-IIIB Stages

Interventions

Cadonilimab

DRUG

radiotherapy

RADIATION

carboplatin, paclitaxel

DRUG

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NCT06342167

Locally Advanced Esophageal Squamous Cell CarcinomaSintilimab+3 more

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UNKNOWNPHASE2

AK104 Alone or in Combination With Chemotherapy in the First-line Treatment of ESCC

NCT05522894

Unresectable Esophageal Squamous Cell CarcinomaLocally Advanced Esophageal Squamous Cell Carcinoma+1 more

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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: March 25, 2025Data 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.

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