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Trial Title:
Consolidation of Toripalimab After Chemoradiotherapy in Elderly Esophageal Cancer (EC-CRT-007)
NCT ID:
NCT06187597
Condition:
Locally Advanced Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Tegafur
Conditions: Keywords:
Esophageal squamous cell carcinoma
Chemoradiotherapy
Immunotherapy
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:
Drug
Intervention name:
S-1
Description:
Patients received S-1 administration, 70mg/m2 per day, orally on days 1 to 14 and 29 to
42 during radiotherapy.
Arm group label:
The control group
Arm group label:
The study group
Other name:
Tegafur,Gimeracil and Oteracil Potassium Capsules
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Patients received toripalimab 240 mg every 3 weeks for up to 16 cycles.
Arm group label:
The study group
Other name:
Toripalimab Injection
Intervention type:
Radiation
Intervention name:
Intensity-modulated radiotherapy
Description:
All patients received external-beam radiation using intensity-modulated radiotherapy. The
prescribed dose is 54 Gy in 27 fractions over 5-6 weeks.
Arm group label:
The control group
Arm group label:
The study group
Other name:
IMRT
Summary:
Although definitive chemoradiotherapy (CRT) is the standard treatment option for
unresectable locally advanced esophageal cancer, elderly patients tolerate intravenous
concurrent CRT less well with age and comorbidities. Previous trials have demonstrated
that CRT with oral S-1 was tolerable and provided significant survival benefits over
radiotherapy alone in elderly patients with esophageal squamous cell carcinoma (ESCC).
However, as high as 54% of patients with elderly ESCC experienced locoregional or distant
recurrence after CRT. Therefore, a more effective regimen for older patients is needed.
Immune checkpoint inhibitors targeting PD-1/PD-L1 have shown substantial clinical
benefits in advanced esophageal cancer. Recently, the combination of immunotherapy with
CRT has emerged as a promising strategy to improve clinical outcomes in locally advanced
esophageal cancer. The aim of this study was to evaluate the efficacy and safety of
toripalimab (an anti-PD-1 antibody) after concurrent CRT in elderly patients with locally
advanced ESCC.
Detailed description:
A total of 140 patients with elderly, unresectable, locally advanced ESCC will be
stratified according to age (70-80 vs. ≥80) and TNM stage (I/II vs. III/IV) and randomly
assigned (1:1) to receive toripalimab as consolidation therapy for up to 12 months (arm
A) or not (arm B) after definitive radiotherapy with concurrent S-1.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically confirmed squamous cell carcinoma of the esophagus;
2. Locally advanced, and absence of hematogenous metastasis disease according to UICC
TNM version 8;
3. Not suitable for surgery (either for medical reasons or patient's choice);
4. Age at diagnosis 70 to 85 years;
5. No prior cancer therapy;
6. Estimated life expectancy >6 months;
7. Eastern Cooperative Oncology Group performance status ≤ 2
8. No history of concomitant or previous malignancy;
9. The function of important organs meets 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;
10. Ability to understand the study and sign informed consent.
Exclusion Criteria:
1. Patients who have been treated previously with anti-tumor therapy (including
chemotherapy, radiotherapy, surgery, immunotherapy, etc.);
2. Patients with hematogenous metastasis disease or esophageal fistula at diagnosis;
3. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any
ingredients of cadonilimab, and the chemotherapeutic drugs paclitaxel or cisplatin;
4. Patients who have a preexisting or coexisting bleeding disorder;
5. Inability to provide informed consent due to psychological, familial, social and
other factors;
6. Presence of CTC grade ≥2 peripheral neuropathy;
7. A history of malignancies other than esophageal cancer before enrollment, excluding
non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
8. A history of diabetes for more than 10 years and poorly controlled blood glucose
levels;
9. Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or
kidney dysfunction, or hematopoietic disease or cachexia.
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. A history of active pulmonary tuberculosis infection within 1 year or a history of
active pulmonary tuberculosis infection more than 1 year ago but without formal
anti-tuberculosis treatment;
13. 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:
70 Years
Maximum age:
85 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Mian Xi
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Mian Xi, MD
Phone:
862087343385
Email:
ximian@sysucc.org.cn
Start date:
March 1, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Nanfang Hospital, Southern Medical University
Agency class:
Other
Collaborator:
Agency:
Zhujiang Hospital
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Xiangya Hospital of Central South University
Agency class:
Other
Collaborator:
Agency:
Wuhan 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/NCT06187597
