Back to resultsRadiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Metastatic Esophageal Squamous Cell Carcinoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
LDRT+CFRT
Immunotherapy
Chemotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Squamous Cell Carcinoma focused on measuring Immunotherapy, low-dose radiotherapy, Esophageal squamous cell carcinoma, Immunoradiotherapy
Eligibility Criteria
Inclusion Criteria: Age ≥18; Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology; ECOG performance status: 0-1 point; No prior anti-tumor treatment; Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators. Exclusion Criteria: Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer; Patients who are potentially curable with surgery as assessed by investigators; Pleural metastasis or malignant pleural effusion, pericardial effusion; Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy; High risk of gastrointestinal bleeding, esophageal fistula, or perforation; Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9; Unstable cardiac diseases or symptoms; History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease; Active autoimmune disease or history of autoimmune disease; Conditions of immunodeficiency or active infection requiring systemic therapy; Pregnant or breastfeeding; Patients with synchronous second primary cancer and a history of malignancy within the past 5 years (excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin carcinoma).
Sites / Locations
- Shanghai Ruijin HospitalRecruiting
- Shanghai Chest HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm A
Arm B
Arm Description
PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin+ Low-dose radiotherapy (LDRT) + Conventionally fractionated radiotherapy (CFRT)
PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin
Outcomes
Primary Outcome Measures
PFS
Progression-free survival
Secondary Outcome Measures
OS
Median overall survival
Incidence of Grade III and higher treatment-related adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05978193
Brief Title
Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
Official Title
First-line Anti-PD-1 Therapy Plus Chemotherapy With or Without Radiotherapy in Metastatic Esophageal Squamous Cell Carcinoma: A Phase II Multi-center, Randomized Trial (SCR-ESCC-01)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Chest Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
SCR-ESCC-01 is a multicenter, randomized, phase II study aiming to investigate the benefit of early involvement of low-dose radiotherapy(LDRT) and conventionally fractionated radiotherapy(CFRT) in the first-line anti-PD-1 based treatment of metastatic ESCC.
Detailed Description
In metastatic esophageal cancer, radiotherapy is often administered for palliative purposes to alleviate the symptom of dysphagia. Recent studies have shown that the combination of radiotherapy and immunotherapy may have a synergistic effect on treatment outcomes. The study aims to investigate the benefit of LDRT in combination with conventionally fractionated radiotherapy (CFRT) in improving the outcome of metastatic ESCC concurrently treated with first-line immunochemotherapy. The recruited patients will be randomly (1:1) assigned to receive either PD-1 inhibitor plus chemotherapy (paclitaxel and platinum regimen) (arm B) or in combination with LDRT and CFRT (arm A). The primary endpoint is median progression-free survival (PFS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Squamous Cell Carcinoma, Esophageal Cancer, Metastatic Esophageal Squamous Cell Carcinoma
Keywords
Immunotherapy, low-dose radiotherapy, Esophageal squamous cell carcinoma, Immunoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm A
Arm Type
Experimental
Arm Description
PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin+ Low-dose radiotherapy (LDRT) + Conventionally fractionated radiotherapy (CFRT)
Arm Title
Arm B
Arm Type
Active Comparator
Arm Description
PD-1 inhibitor + Paclitaxel + Cisplatin/Carboplatin
Intervention Type
Radiation
Intervention Name(s)
LDRT+CFRT
Intervention Description
LDRT: Primary tumor and all visible metastatic lesions, DT: 2Gy/2fx, d1-2, Q3W × 4 cycles
; CFRT: Primary tumor, DT:40-50Gy/20-25fx, starting from the 5th immunotherapy cycle
Intervention Type
Drug
Intervention Name(s)
Immunotherapy
Intervention Description
PD-1 inhibitor 200mg, Q3W, until disease progression or unacceptable toxicity or treatment reaches 2 years
Intervention Type
Drug
Intervention Name(s)
Chemotherapy
Intervention Description
Paclitaxel+ Cisplatin, Q3W × 4cycles or Paclitaxel+ Carboplatin, Q3W × 4 cycles
Primary Outcome Measure Information:
Title
PFS
Description
Progression-free survival
Time Frame
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary Outcome Measure Information:
Title
OS
Description
Median overall survival
Time Frame
From date of randomization until the date of death from any cause, assessed up to 36 months
Title
Incidence of Grade III and higher treatment-related adverse events
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18;
Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by pathology;
ECOG performance status: 0-1 point;
No prior anti-tumor treatment;
Adequate hematologic, renal, hepatic, and cardiac functions that meet the requirements for chemotherapy and immunotherapy assessed by investigators.
Exclusion Criteria:
Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types of esophageal cancer;
Patients who are potentially curable with surgery as assessed by investigators;
Pleural metastasis or malignant pleural effusion, pericardial effusion;
Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy, chemotherapy, or immunotherapy;
High risk of gastrointestinal bleeding, esophageal fistula, or perforation;
Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;
Unstable cardiac diseases or symptoms;
History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary fibrosis, or other uncontrolled acute pulmonary disease;
Active autoimmune disease or history of autoimmune disease;
Conditions of immunodeficiency or active infection requiring systemic therapy;
Pregnant or breastfeeding;
Patients with synchronous second primary cancer and a history of malignancy within the past 5 years (excluding completely cured cervical carcinoma in situ or basal cell or squamous cell skin carcinoma).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Yu, M.D
Phone
021-22200000-3203
Email
yuzhiwen0827@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Yu, M.D
Organizational Affiliation
Shanghai Chest Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200020
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sheng-guang Zhao
Phone
021-34186000
Facility Name
Shanghai Chest Hospital
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Yu
Phone
021-22200000-3203
Email
yuzhiwen0827@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
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