Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05621707
Other study ID # drjunliu
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date November 20, 2022
Est. completion date November 19, 2026

Study information

Verified date November 2022
Source Shanghai Chest Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is an investigator-initiated, single-arm, exploratory clinical study.The study population consisted of non-operative Locally Advanced Esophageal Cancer . The purpose of this study was to evaluate the efficacy and safety of Concurrent Chemoradiotherapy Following Immunotherapy Plus Chemotherapy for Patients With Locally-advanced Esophageal Squamous Cell Cancer.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date November 19, 2026
Est. primary completion date November 19, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Age:18-75 years of age; 2. Histologically confirmed squamous cell carcinoma; 3. locally-advanced ,medical inoperability, technical irresectability, or patient refusal to surgery; 4. Eastern Cooperative Oncology Group (ECOG) performance status:0-2; 5. Able to eat a semi-liquid diet; 6. Less than 20% weight loss within 6 months; 7. Adequate hepatic function, renal function, hematologic function and coagulation function; 8. Documented informed consent. Exclusion Criteria: 1. Distant metastasis; 2. Known malignancy diagnosed or require active treatment in the last 5 years, except for cancers that can be cured by surgery including cervical cancer in situ, basal or squamous cell skin cancer, breast ductal carcinoma in situ, localized prostate cancer; 3. Prior thoracic irradiation, chemotherapy, or lobectomy 4. Known diseases or conditions that are contraindicated for radiotherapy or surgery; 5. Allergy to the research medications; 6. Pregnant women or women preparing for pregnancy; 7. Diagnosis of autoimmune disease or history of chronic autoimmune disease 8. Absence of informed consent because of psychological, family, social and other factors; 9. Patients with comorbidities (chronic pulmonary disease, poorly controlled hypertension, unstable angina, myocardial infarction within 6 months, unstable mental disorders requiring therapy).

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
chemotherapy combined with PD-1 inhibitors
Induction chemotherapy combined with PD-1 inhibitors followed with standard concurrent chemoradiotherapy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shanghai Chest Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Overall Survival Rate Overall survival rate is defined as the percentage of participants who are alive up to 3 years from enrollment 3 years after last patient enrolled
Secondary progression-free Survival (PFS) Progression-free survival is defined as the time between date of enrollment and first date of recurrence or death, whichever occurs first.Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary tumor site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as PFS events. 3 years after last patient enrolled
Secondary Treatment related complications complications after treatment During the procedure
See also
  Status Clinical Trial Phase
Recruiting NCT05848011 - A Study of Lorigerlimab With Docetaxel or Docetaxel Alone in Participants With Metastatic Castration-Resistant Prostate Cancer Phase 2
Recruiting NCT05161572 - Perioperative Chemoimmunotherapy With/Without Preoperative Chemoradiation for Locally Advanced Gastric Cancer Phase 2
Recruiting NCT06165900 - Stereotactic Radiotherapy Combined With Adebrelimab and TCb (Nab-paclitaxel + Carboplatin) in Neoadjuvant Treatment of TNBC Phase 2
Recruiting NCT06120127 - Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence Phase 2
Recruiting NCT06262581 - Neoadjuvant Tisleizumab(BGB-A317) for dMMR/MSI-H Non-late Stage CRC Patients Before Surgery Phase 2
Recruiting NCT05176002 - Camrelizumab in Combination With Radiotherapy for Neoadjuvant Esophageal Carcinoma. Phase 1/Phase 2
Not yet recruiting NCT05909137 - Omitting Clinical Target Volume in Radical Treatment of Unresectable Stage III Non-small Cell Lung Cancer
Recruiting NCT04500990 - MRI DWI None-Gaussian Model Predicting Early Response to Immunotherapy in Digestive System Malignancies: a Prospective Observational Study
Not yet recruiting NCT04372732 - Serum Autoantibodies in Predicting the Efficacy of Anti-PD-1 Treatment in Patients With Advanced NSCLC
Completed NCT02692976 - Natural Dendritic Cells for Immunotherapy of Chemo-naive Metastatic Castration-resistant Prostate Cancer Patients Phase 2
Completed NCT03763630 - MAPS & ITEC Cohorts: 6-8 Years Follow-up Phase 2
Not yet recruiting NCT06012318 - Dynamic Follow-up of Symptoms Based on Patient-reported Outcomes in Immunotherapy for Esophageal Cancer: a Prospective Multicentre Cohort Study (SPRING)
Not yet recruiting NCT05479240 - Neoadjuvant Chemoradiotherapy Combined With Tislelizumab in the Treatment of Locally Advanced Rectal Cancer Phase 2
Recruiting NCT04711330 - Response and Toxicity Prediction by Microbiome Analysis After Concurrent Chemoradiotherapy
Recruiting NCT05515796 - Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors Phase 2
Recruiting NCT03701607 - Effect of Chemotherapy on PD-L1 in NSCLC
Recruiting NCT03683407 - Effect of Chemotherapy on TMB in NSCLC
Completed NCT03357861 - Cancer Patients Treated With Immunotherapy in Intensive Care Unit
Recruiting NCT05223088 - Tislelizumab Combined With Apatinib and Oxaliplatin Plus S1 as Neoadjuvant Therapy for Borrmann IV、Large Borrmann III Type and Bulky N Positive Advanced Gastric Cancer Phase 2
Completed NCT05657262 - Effect of Z Technıque on Pain, Comfort, Symptoms in Ummunotherapy Areas N/A