Loading clinical trials...

Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2

Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma

Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma: a Open-label, Randomized, Controlled Phase II Clinical Trial

NCT06281886•Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Detailed Description

This is an open-label, randomized, controlled phase II study evaluating induction immuno-chemotherapy and concurrent chemoradiotherapy with or without apatinib in unresectable, locally advanced esophageal squamous cell carcinoma. In this study, patients are 1:1 randomized to either the study group or the control group. Patients in the study group will receive apatinib during induction immuno-chemotherapy and concurrent chemoradiotherapy. Patients in the control group will receive induction immuno-chemotherapy and concurrent chemoradiotherapy alone.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Diagnosed with esophageal squamous cell carcinoma through pathological examination or cytological examination;
•Evaluated as locally advanced esophageal cancer that is unresectable through endoscopic ultrasound, imaging studies including barium swallow, CT scans of the neck, chest, and upper abdomen, MR imaging of the neck and chest, whole-body bone scan, or PET/CT, with staging ranging from T2-4, N0-3, M0-1 (M1 only includes patients with supraclavicular lymph node metastasis);
•Male or female aged between 18 and 80 years old;
•No prior chemotherapy, radiotherapy, surgery, targeted therapy, or immunotherapy;
•Expected survival of ≥12 weeks;
•ECOG performance status score of 0 or 1;
•Organ and bone marrow function meeting the following criteria: forced expiratory volume in 1 second (FEV1) ≥800 ml; absolute neutrophil count ≥1.5×109/L; platelet count ≥100×109/L; hemoglobin ≥90 g/L; serum creatinine clearance calculated according to the Cockcroft-Gault formula ≥50 mL/min (Cockcroft and Gault 1976); serum bilirubin ≤1.5 times the upper limit of normal (ULN); aspartate aminotransferase and alanine aminotransferase ≤2.5 times ULN;
•Signed and dated informed consent form is required before any study procedures are performed.

Exclusion Criteria

•Participating in another clinical study concurrently, unless it is an observational (non-interventional) clinical study;
•Prior use of any targeted therapy or immunotherapy;
•Underwent major surgery (excluding vascular access) within 4 weeks before entering the study;
•Uncontrolled complications, including but not limited to persistent or active infections, symptomatic congestive heart failure, poorly controlled hypertension, unstable angina, arrhythmias, active peptic ulcer disease or gastritis, intestinal perforation, intestinal obstruction, active bleeding disorders, or psychiatric illness/social situations that would limit compliance with study requirements or impair the ability to provide written informed consent;
•Performance status score of 2-4;
•Any of the following organ and bone marrow dysfunctions: forced expiratory volume in 1 second (FEV1) \<1000ml; absolute neutrophil count \<1.5×109/L; platelet count \<100×109/L; hemoglobin \<90 g/L; serum creatinine clearance calculated according to the Cockcroft-Gault formula \<50 mL/min (Cockcroft and Gault 1976); serum bilirubin \>1.5 times the upper limit of normal (ULN); aspartate aminotransferase and alanine aminotransferase \>2.5 times ULN;
•Conditions that may interfere with the assessment of the efficacy or safety of apatinib;
•Use of immunosuppressive drugs within 28 days before the first infusion of trastuzumab, excluding physiologic doses of inhaled corticosteroids; or systemic corticosteroids ≤10 mg/d of prednisone or equivalent;
•History of autoimmune diseases within the past 2 years;
•History of active or inflammatory bowel disease (such as Crohn's disease, ulcerative colitis);
+4 more criteria

Locations (1)

Sun yat-sen University Cancer Center

Guangzhou, Guangdong, China

Key Dates

Start Date

December 1, 2023

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

November 17, 2025

Enrollment

170

ESTIMATED participants

Conditions

Esophageal Squamous Cell CarcinomaEfficacyToxicity

Interventions

Induction Immunotherapy-Toripalimab

DRUG

Induction Chemotherapy-Albumin-paclitaxel combined with cisplatin

DRUG

Radiotherapy

RADIATION

Apatinib

DRUG

Capecitabine

DRUG

Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger

NCT07256522

Trigger FingerSplint Therapy+4 more

View study

RECRUITING

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

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 17, 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.

View ClinicalTrials.gov Terms and Conditions

Induction Immuno-chemotherapy and Concurrent Chemoradiotherapy With or Without Apatinib in Unresectable, Locally Advanced Esophageal Squamous Cell Carcinoma

Inclusion Criteria

Exclusion Criteria

Comparative Evaluation of Finger Splint, Paraffin, and Peloidotherapy Interventions in the Management of Trigger Finger

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

Vebrekotuzumab ± Anti-PD-1 in Pretreated Advanced ESCC

Protecting the Kidney's Proximal Tubules From Platinum-Based Chemotherapy Toxicity

Human Amniotic-Derived Mesenchymal Stem Cell Therapy for Calciphylaxis

Neoadjuvant Adebrelimab Plus Chemotherapy for Esophageal Cancer: A Clinical Study