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Trial Title:
Radiotherapy Combined With Immunochemotherapy in Metastatic Esophageal Squamous Cell Carcinoma
NCT ID:
NCT05978193
Condition:
Esophageal Squamous Cell Carcinoma
Esophageal Cancer
Metastatic Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Immunomodulating Agents
Conditions: Keywords:
Immunotherapy
low-dose radiotherapy
Esophageal squamous cell carcinoma
Immunoradiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
LDRT+CFRT
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
Arm group label:
Arm A
Intervention type:
Drug
Intervention name:
Immunotherapy
Description:
PD-1 inhibitor 200mg, Q3W, until disease progression or unacceptable toxicity or
treatment reaches 2 years
Arm group label:
Arm A
Arm group label:
Arm B
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Paclitaxel+ Cisplatin, Q3W × 4cycles or Paclitaxel+ Carboplatin, Q3W × 4 cycles
Arm group label:
Arm A
Arm group label:
Arm B
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).
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Age ≥18;
2. Metastatic esophageal squamous cell carcinoma (stage IVB, M1) confirmed by
pathology;
3. ECOG performance status: 0-1 point;
4. No prior anti-tumor treatment;
5. Adequate hematologic, renal, hepatic, and cardiac functions that meet the
requirements for chemotherapy and immunotherapy assessed by investigators.
Exclusion Criteria:
1. Non-squamous cell esophageal carcinoma or ESCC mixed with other pathological types
of esophageal cancer;
2. Patients who are potentially curable with surgery as assessed by investigators;
3. Pleural metastasis or malignant pleural effusion, pericardial effusion;
4. Any prior anti-tumor therapy for esophageal cancer, i.e., surgery, radiotherapy,
chemotherapy, or immunotherapy;
5. High risk of gastrointestinal bleeding, esophageal fistula, or perforation;
6. Patients with Patient-Generated Subjective Globe Assessment (PG-SGA) score≥9;
7. Unstable cardiac diseases or symptoms;
8. History of interstitial pulmonary disease, non-infectious pneumonitis; pulmonary
fibrosis, or other uncontrolled acute pulmonary disease;
9. Active autoimmune disease or history of autoimmune disease;
10. Conditions of immunodeficiency or active infection requiring systemic therapy;
11. Pregnant or breastfeeding;
12. 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Ruijin Hospital
Address:
City:
Shanghai
Zip:
200020
Country:
China
Status:
Recruiting
Contact:
Last name:
Sheng-guang Zhao
Phone:
021-34186000
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Wen Yu
Phone:
021-22200000-3203
Email:
yuzhiwen0827@163.com
Start date:
January 1, 2023
Completion date:
January 1, 2027
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05978193
