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Trial Title:
Combination of Tislelizumab and Chemoradiotherapy in Esophageal Cancer (EC-CRT-002)
NCT ID:
NCT05520619
Condition:
Esophageal Squamous Cell Carcinoma
Locally Advanced Esophageal Squamous Cell Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Esophageal Squamous Cell Carcinoma
Paclitaxel
Tislelizumab
Conditions: Keywords:
Esophageal Squamous Cell Carcinoma
Induction chemotherapy
Definitive chemoradiotherapy
Tislelizumab
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:
Paclitaxel, Cisplatin
Description:
Patients received 2 cycles of induction chemotherapy with paclitaxel/cisplatin
(paclitaxel 135-175mg/m2 and cisplatin 75 mg/m2) prior to radiotherapy. Then patients
will receive paclitaxel 45mg/m2 and cisplatin 25 mg/m2 once weekly for 5 weeks during
radiotherapy.
Arm group label:
Tislelizumab plus CRT with maintenance
Arm group label:
Tislelizumab plus CRT without maintenance
Other name:
Taxol
Intervention type:
Drug
Intervention name:
tislelizumab
Description:
Patients received tislelizumab 200 mg every 3 weeks for 16 cycles in Arm A and 4 cycles
in Arm B.
Arm group label:
Tislelizumab plus CRT with maintenance
Arm group label:
Tislelizumab plus CRT without maintenance
Intervention type:
Radiation
Intervention name:
Radiotherapy
Description:
All patients received external-beam radiation using intensity-modulated radiotherapy. The
prescribed dose is 50.4 Gy in 28 fractions over 5-6 weeks.
Arm group label:
Tislelizumab plus CRT with maintenance
Arm group label:
Tislelizumab plus CRT without maintenance
Other name:
intensity-modulated radiotherapy
Summary:
Definitive chemoradiotherapy (CRT) is the standard treatment option for unresectable
locally advanced esophageal cancer (EC). However, as high as more than 40% of EC patients
experienced locoregional recurrence after concurrent CRT. Immunotherapy targeting the
PD-1/PD-L1 checkpoints has demonstrated promising activity in advanced EC. Recently, the
combination of immunotherapy with CRT has emerged as a promising strategy to improve
clinical outcomes in EC. The aim of this study was to evaluate whether the efficacy of
tislelizumab (an anti-PD-1 antibody) plus induction chemotherapy followed by concurrent
chemoradiotherapy would achieve a ≥71% 1-year progression-free survival rate, surpassing
the historical 56% rate (NCT02403531) in patients with locally advanced esophageal
squamous cell carcinoma (ESCC).
Detailed description:
A total of 114 patients with unresectable, locally advanced ESCC will be randomized to
receive either tislelizumab plus induction chemotherapy followed by concurrent CRT and
then 12 additional cycles of tislelizumab (Arm A) or tislelizumab plus the same induction
and concurrent regimen without the maintenance of tislelizumab (Arm B).
Patients will receive 2 cycles of 3-weekly schedule of induction chemotherapy, consisting
of paclitaxel 135-175 mg/m2, cisplatin 75 mg/m2, and tislelizumab 200mg on day 1 prior to
CRT. Then all patients will receive standard fractionation radiation therapy scheme: 50.4
Gy in 28 fractions, concurrently with paclitaxel 45mg/m2 and cisplatin 25 mg/m2 once
weekly for 5 weeks and 2 cycles of tislelizumab. Patients in Arm A will receive 12
additional cycles of tislelizumab after the completion of CRT.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Histologically confirmed squamous cell carcinoma of the esophagus;
2. Locally advanced, and absence of hematogenous metastasis disease, confirmed by
endoscopic ultrasound (EUS) and PET-CT scan (according to UICC TNM version 8);
3. Not suitable for surgery (either for medical reasons or patient's choice);
4. Age at diagnosis 18 to 70 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 at diagnosis;
3. Known or suspected allergy or hypersensitivity to monoclonal antibodies, any
ingredients of Toripalimab, and the chemotherapeutic drugs paclitaxel or cisplatin;
4. Patients who have a preexisting or coexisting bleeding disorder;
5. Female patients who are pregnant or lactating;
6. Inability to provide informed consent due to psychological, familial, social and
other factors;
7. Presence of CTC grade ≥ 3 peripheral neuropathy;
8. A history of malignancies other than esophageal cancer before enrollment, excluding
non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer
9. A history of diabetes for more than 10 years and poorly controlled blood glucose
levels;
10. Patients who cannot tolerate chemoradiotherapy due to severe cardiac, lung, liver or
kidney dysfunction, or hematopoietic disease or cachexia.
11. 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;
12. A history of interstitial lung disease or non-infectious pneumonia;
13. 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;
14. 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:
Mian Xi
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Mian Xi, MD
Phone:
+862087343492
Email:
ximian@sysucc.org.cn
Start date:
September 15, 2022
Completion date:
July 31, 2026
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Zhongshan People's Hospital, Guangdong, China
Agency class:
Other
Collaborator:
Agency:
Jieyang People's Hospital
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/NCT05520619