- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06122493
Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma
November 6, 2023 updated by: Ruijin Hospital
Optimization of Treatment Strategy for Unresectable cN3 Esophageal Squamous Cell Carcinoma: a Phase Ⅱ Single Arm Prospective Study
This study aims to investigate a comprehensive therapeutic approach for patients with unresectable esophageal squamous cell carcinoma, clinically staged as Tany, N3, M0, and who are not candidate for concurrent chemoradiotherapy combined with immunotherapy.
The approach entails combining chemotherapy with immune therapy, followed by synchronized radiotherapy during the immune maintenance phase.
The primary goal is to mitigate treatment-related side effects and enhance the overall prognosis through the integration of these treatment modalities.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Eligible ESCC patients receive a four-cycle regimen of combined chemotherapy plus immunotherapy.
Those without disease progression then get definitive radiotherapy with immune maintenance therapy for up to 12 months.
Study Type
Interventional
Enrollment (Estimated)
48
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yifeng Wang
- Phone Number: 0086-021-64370045
- Email: ruijincrc@126.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200025
- Recruiting
- Ruijin Hospital, Shanghai Jiaotong University School Of Medicine
-
Contact:
- Shengguang Zhao
-
Principal Investigator:
- Shengguang Zhao
-
Sub-Investigator:
- Shuyan Li
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Esophageal squamous cell carcinoma confirmed through histopathology.
- Distant metastasis excluded by CT, MRI, or PET/CT examinations.
- Locally advanced stage: AJCC/UICC eighth edition staging with any T, N3M0.
- Expected survival time of at least 6 months.
- With an ECOG performance status of 0 to 2. Not accompanied by severe pulmonary hypertension, cardiovascular disease, peripheral vascular disease, severe chronic heart disease, or other comorbidities that could impact radiotherapy progress.
- Adequate function of major organs: Hematopoietic function: Hemoglobin ≥100g/L, platelets ≥90×109/L, white blood cells ≥4×109/L. Exceptions may be considered for patients with ECOG 0-1 who have a history of chronic anemia (80-100 g/L), previous low white blood cell levels (3-4×109/L), or reduced platelets (80-90×109/L). Liver function: ALT and AST <1.5 times the upper limit of normal (ULN), bilirubin <1.5×ULN. Renal function: Serum creatinine (SCR) ≤140 μmol/L.
- Patients are required to provide informed consent to undergo treatment.
Exclusion Criteria:
- Existing or prior history of other malignant tumors (except non-melanoma skin cancer) that are uncontrolled or not cured, depending on the type of the primary tumor.
- Lack of histological or cytological diagnosis for esophageal cancer.
- Previous chest radiotherapy.
- Suffering from innate or acquired immune function defects;
- Pregnancy (confirmed by serum or urine β-HCG test) or during the lactation period; History of drug abuse or alcohol dependence; HIV-positive status, including those on antiretroviral treatment; Chronic hepatitis B with viral replication phase; Active phase of hepatitis C; Active syphilis with a history of mental illness that may hinder treatment completion.
- Poor overall health status, defined as KPS < 70 or ECOG > 2.
- Presence of severe comorbidities that could impact radiotherapy progress, including: Unstable angina, congestive heart failure, or myocardial infarction requiring hospitalization within the past 6 months; Acute bacterial or systemic fungal infections; Exacerbation of chronic obstructive pulmonary disease or other respiratory conditions requiring hospitalization; Hepatic or renal insufficiency; Immunosuppressed patients; Coexisting connective tissue diseases, such as active scleroderma or lupus, which are contraindications to radiotherapy.
- Inability to comprehend the treatment's purpose or unwillingness to sign the treatment consent form.
- Lack of legal capacity or limited legal capacity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: chemotherapy-immunotherapy-radiotherapy
Carboplatin (AUC = 5, d1) and nab-paclitaxel (175 mg/m², day1) will be administered every 3 weeks for four cycles.Tislelizumab (200 mg) will be administered every 3 weeks for up to 12 months.
Radiotherapy targeting esophageal lesions and positive lymph nodes, with a total dose of 50.4 Gy over 28 fractions will be delivered.
|
immunotherapy, 200 mg on day 1 per 3 weeks
Other Names:
chemotherapy, 175 mg/m² on day 1 per 3 weeks
Other Names:
chemotherapy, AUC=5 on day 1 per 3 weeks
Other Names:
Patients without disease progression after four cycles of chemoimmunotherapy receive radiotherapy targeting esophageal lesions and positive lymph nodes, with a total dose of 50.4 Gy delivered over 28 fractions.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1-year progression-free survival
Time Frame: 1 year
|
From the initial administration of the study drug to the first identification of disease progression or mortality, whichever happens first.
In the case of patients who had not encountered local control failure or death, specifically in terms of progression-free survival, the time of the last tumor assessment was considered as the endpoint.
Tumor response was evaluated by investigators following RECIST v1.1 criteria.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute toxicity
Time Frame: 3 months
|
Monitor the occurrence of acute toxic reactions (based on CTCAE4.03) and subacute toxic reactions (RTOG) in the treatment of cN3 ESCC with the combination of chemotherapy, immunotherapy, and ongoing radiotherapy, both during the treatment course and within three months after its completion.
|
3 months
|
Quality of Life (QoL)
Time Frame: 1 years
|
Collect QoL data on cN3 ESCC patients.
The data is measured by EORTC QLQ-C30 (Version 3.0) according to investigator collection at the starting and ending time of the treatment.
EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients.
The core and disease-specific for ESCC modules are selected to estimate treatment related influence on patients' life.
The final score of the questionnaire is collected and analyzed according to detailed scoring procedures from manuals.
|
1 years
|
Objective response rate
Time Frame: 1 year
|
Defined as the proportion of patients with complete response (CR) or partial response (PR)
|
1 year
|
Duration of response
Time Frame: 1 year
|
Defined as the period from the recognition of an objective response to the first identification of either progression or death, whichever event transpired first.
|
1 year
|
Disease control rate
Time Frame: 1 year
|
Defined as the proportion of patients with complete response (CR), partial response (PR) and stable disease (SD)
|
1 year
|
Immune Progression Free Survival
Time Frame: 1 year
|
defined as the duration from the initial dose of tislelizumab to the first identification of either disease progression or death, whichever happens first.
Tumor response was evaluated by investigators following iRECIST criteria.
|
1 year
|
Overall survival
Time Frame: 1 year
|
defined as the period from the initial drug administration to the subject's demise from various causes.
In cases where patients were lost to follow-up prior to their passing, the date of their last documented contact was documented.
For patients still alive at the last analyzed time point, the time of their last contact was considered as their survival duration.
In the analysis of survival and subsequent treatment, all patients were monitored until their death, loss to follow-up, or the conclusion of the study.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2022
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
October 18, 2023
First Submitted That Met QC Criteria
November 6, 2023
First Posted (Estimated)
November 8, 2023
Study Record Updates
Last Update Posted (Estimated)
November 8, 2023
Last Update Submitted That Met QC Criteria
November 6, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Head and Neck Neoplasms
- Esophageal Diseases
- Neoplasms, Squamous Cell
- Esophageal Neoplasms
- Carcinoma
- Carcinoma, Squamous Cell
- Esophageal Squamous Cell Carcinoma
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Carboplatin
- Paclitaxel
Other Study ID Numbers
- RuijinH 2022(270)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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