Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

Trial Title: Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

NCT ID: NCT06421376

Condition: Esophageal Cancer
Immunotherapy
Induction Therapy
Chemoradiotherapy
Surgery

Conditions: Official terms:
Esophageal Neoplasms
Immunomodulating Agents

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: Cardonilizumab
Description: Two cycles of Inductive therapy： nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles
Arm group label: Inductive chemoimmunotherapy+chemoradiotherapy±surgery

Intervention type: Radiation
Intervention name: Chemoradiotherapy ±immunotherapy
Description: Chemoradiotherapy ± immunotherapy： - PTV: 50-50.4Gy/1.8-2Gy/25-28fractions ②nab-paclitaxel 100mg+cisplatin 25mg/ m2, d1, every 7 days for 3-5 weeks ③Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles
Arm group label: Inductive chemoimmunotherapy+chemoradiotherapy±surgery

Intervention type: Procedure
Intervention name: Radical surgery
Description: Surgery was evaluated after concurrent chemoradiotherapy according to patients willing and the surgeons' assessment. If patients were accessed with unresectable disease after radiotherapy or refused to receive surgery, Cardonilizumab would be administered for 2 years or until disease progression.
Arm group label: Inductive chemoimmunotherapy+chemoradiotherapy±surgery

Summary: Although unprecedented advances have been made in the field of esophageal cancer in recent decades, the prognosis for patients with locally advanced esophageal squamous cell carcinoma (ESCC) remains extremely poor, accounting for 30-40% of overall survival at 5 year. In recent years, multimodal treatments have proven to be an appropriate therapeutic approach for locally advanced ESCC. Recently, immunotherapy developed rapidly. The purpose of this study was to observe the efficacy and safety of cardonilizumab combined with chemoradiotherapy in the treatment of locally advanced ESCC.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 18-80 years old； - Eligible patients were histologically confirmed esophageal squamous cell carcinoma; - Eligible patients were proven locally advanced ESCC (cT1-2N1-3M0-1, cT3/T4N0-3M0-1, M1 was limited to supraclavicular lymph node metastasis）diagnosed by computed tomography [CT] and/or endoscopic ultrasonography [EUS] according to the American Joint Committee on Cancer (AJCC) 8th edition staging system； - ECOG PS score: 0~1； - Main organs and bone marrow function are normal: routine blood tests: hemoglobin (Hb) ≥100g/L ; absolute neutrophil count (NEUT)≥1.5×109/L; platelets (PLT) ≥100×109/L; white blood cell (WBC)≥3.5×109/L,biochemical examination: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤1.5×UNL; serum total bilirubin (TBIL) ≤1.5×UNL; serum creatinine ( Cr) 1.0×1.5UNL, and BUN≤1.0×UNL; Exclusion Criteria: - Those combined with other primary malignant tumors other than esophageal cancer (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix); - patients who had previously received other treatments - At the time of diagnosis, there were distant and hematogenous metastases beyond the supraclavicular lymph node region, including retroperitoneal multiple lymph node metastasis, bone metastasis, brain metastasis, lung metastasis, liver metastasis, malignant pleural effusion and ascites - Those who already have esophageal perforation or are at high risk of esophageal perforation - Patients whose tumors invade close to large blood vessels and are at risk of bleeding in the - there are active infections, such as active tuberculosis and hepatitis - There are contraindications to immunotherapy. - Pregnant or lactating women and women of childbearing age do not take reliable contraceptive measures - Combined with serious cardiovascular diseases, such as uncontrolled heart failure, coronary heart disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or a history of myocardial infarction within the past 6 months; and those combined with other uncontrolled acute and chronic diseases such as hypertension and diabetes. - Violation of inclusion and exclusion criteria, or other reasons that the researcher believes cannot continue the study of drug treatment.

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Anyang Cancer Hospital

Address:
City: Anyang
Country: China

Status: Not yet recruiting

Contact:
Last name: Xiaomin Wang, M.D.

Facility:
Name: The First Affiliated Hospital of Xinxiang Medical University

Address:
City: Xinxiang
Country: China

Status: Not yet recruiting

Contact:
Last name: Xiaomei Liu, M.D.

Facility:
Name: Department of Radiation Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC)

Address:
City: Beijing
Zip: 100021
Country: China

Status: Recruiting

Contact:
Last name: Xin Wang, MD

Phone: +861013311583220
Email: beryl_wx2000@163.com

Start date: May 1, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Agency class: Other

Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06421376