To hear about similar clinical trials, please enter your email below
Trial Title:
Anti-PD-1 Immunotherapy Combined With SBRT for Patients With Oligometastatic ESCC
NCT ID:
NCT05626569
Condition:
Esophageal Squamous Cell Carcinoma
Oligometastatic Disease
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Conditions: Keywords:
esophageal cancer; oligometastases; PD-1; SBRT
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PD-1 combined with SBRT
Description:
Anti-PD1 monoclonal antibody combined with SBRT. The SBRT defined as the radiation
prescription with single dose equal or over 4Gy and the fractions less or equal to 10
fractions. BED equal or over 50Gy is required.
Arm group label:
PD-1 combined with SBRT for metastatic lesions
Other name:
SBRT
Summary:
The goal of this phase II clinical trial is to explore the efficacy and safety of
anti-PD1 combined with stereotactic body radiation therapy (SBRT) for patients with
oligometastatic esophageal squamous cell carcinoma. Participants will receive anti-PD1
and SBRT to the metastatic lesions which are amenable to the delivery of SBRT after 4~6
cycles of systemic chemotherapy and anti-PD-1.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Eastern Cooperative Oncology Group performance status ≤ 2;
2. Histologically confirmed squamous cell carcinoma of the esophagus;
3. Diagnosed with stage IVB disease (according to UICC TNM version 8) with less than
five metastatic lesions within three organs;
4. Received 4 to 6 cycles of standard chemotherapy (fluoropyrimidine or taxane-based
platinum doublet chemotherapy) and anti-PD1 treatment, and no progression disease
was confirmed;
5. At least one metastatic lesions amenable to the delivery of SBRT;
6. Estimated life expectancy >4 months;
7. The function of important organs meet the following requirements: a. white blood
cell count (WBC) ≥ 4.0×109/L, absolute neutrophil count (ANC) ≥ 1.5×109/L; b.
platelets ≥ 100×109/L; c. hemoglobin ≥ 9g/dL; d. serum albumin ≥ 2.8g/dL; e. total
bilirubin ≤ 1.5×ULN, ALT, AST and/or AKP ≤ 2.5×ULN; f. serum creatinine ≤ 1.5×ULN or
creatinine clearance rate >60 mL/min;
8. Ability to understand the study and sign informed consent.
Exclusion Criteria:
1. Progression was confirmed after completion of 4 to 6 cycles of standard chemotherapy
and anti-PD1 treatment;
2. Patients with intracranial metastasis disease at diagnosis;
3. History of thoracic irradiation;
4. Known or suspected allergy or hypersensitivity to monoclonal antibodies and the
chemotherapeutic drugs: Capecitabine, paclitaxel, or platinum;
5. Patients have spinal bone metastases combined with spinal cord compression;
6. A history of malignancies other than esophageal cancer before enrollment, excluding
non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer;
7. Patients who cannot tolerate radiotherapy due to severe cardiac, lung, liver, or
kidney dysfunction, or hematopoietic disease or cachexia;
8. Inability to provide informed consent due to psychological, familial, social, and
other factors;
9. Female patients who are pregnant or during lactation;
10. Active autoimmune diseases, a history of autoimmune diseases (including but not
limited to these diseases or syndromes, such as colitis, hepatitis,
hyperthyroidism), a history of immunodeficiency (including a positive HIV test
result), or other acquired or congenital immunodeficiency diseases, a history of
organ transplantation or allogeneic bone marrow transplantation;
11. A history of interstitial lung disease or non-infectious pneumonia; Presence of
active hepatitis B (HBV DNA ≥ 2000 IU/mL or 104 copies/mL), hepatitis C (positive
for hepatitis C antibody, and HCV-RNA levels higher than the lower limit of the
assay).
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Mian Xi
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Baoqing Chen
Phone:
02087340540
Email:
chenbq@sysucc.org.cn
Start date:
December 10, 2022
Completion date:
January 1, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05626569
