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Trial Title:
Concurrent Chemoradiotherapy for Stage IVB Esophageal Squamous Cell Carcinoma（EC-CRT-003）
NCT ID:
NCT05512520
Condition:
Metastatic Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Capecitabine
Conditions: Keywords:
metastatic esophageal squamous cell carcinoma
anti-PD-1
Capecitabine
chemoradiotherapy
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:
Combination Product
Intervention name:
Intensity-modulated radiotherapy concurrent with capecitabine
Description:
All patients received external-beam radiation using intensity-modulated radiotherapy. The
prescribed dose is 45 to 50.4Gy in 25 to 28 fractions, concurrently with 2 cycles of
capecitabine tablets (825mg/m2) for two weeks.
Arm group label:
Concurrent Chemoradiotherapy group
Summary:
Retrospective studies suggested that the addition of thoracic concurrent
chemoradiotherapy to systemic chemotherapy improved the survival and quality of life
(QOL) of patients with metastatic esophageal squamous cell carcinoma (ESCC). However, no
prospective study had been conducted to confirm these findings. Recently, immunotherapy
targeting the PD-1/PD-L1 checkpoints combined with chemotherapy had been proved to
significantly prolong the survival of those patients compared with chemotherapy alone.
Moreover, anti-PD-1 combined with radiotherapy exerts a synergistic anti-tumor effect,
which may further improve the combination efficacy. This randomized, phase II study aimed
to evaluate the efficacy and safety of the chemotherapy and anti-PD-1 combined with
concurrent chemoradiotherapy to primary tumor versus systemic therapy alone in stage IVB
ESCC. Of note, non-regional lymph node metastasis only was the stratification factor in
the random assignment.
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);
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. Estimated life expectancy >4 months;
6. 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;
7. 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 who have a preexisting esophagomediastinal fistula and/or esophagotracheal
fistula;
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 chemoradiotherapy 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;
12. 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:
No
Locations:
Facility:
Name:
Sun yat-sen University Cancer center
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Contact:
Last name:
Baoqing Chen, MD
Phone:
02087340540
Email:
chenbq@sysucc.org.cn
Start date:
September 20, 2022
Completion date:
September 30, 2025
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/NCT05512520
