Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer
- Conditions
- ChemoradiotherapyInduction TherapyEsophageal CancerImmunotherapySurgery
- Interventions
- Drug: CardonilizumabRadiation: Chemoradiotherapy ±immunotherapyProcedure: Radical surgery
- Registration Number
- NCT06421376
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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;
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Inductive chemoimmunotherapy+chemoradiotherapy±surgery Radical surgery In this group, the patients were given 2 cycles of inductive therapy of cardonilizumab combined with chemotherapy, followed by concurrent chemoradiotherapy with two cycles of nab-paclitaxel and cisplatin plus radiotherapy of 50-50.4 Gy. After clinical evaluation, surgery was feasible for a part of patients. Inductive chemoimmunotherapy+chemoradiotherapy±surgery Cardonilizumab In this group, the patients were given 2 cycles of inductive therapy of cardonilizumab combined with chemotherapy, followed by concurrent chemoradiotherapy with two cycles of nab-paclitaxel and cisplatin plus radiotherapy of 50-50.4 Gy. After clinical evaluation, surgery was feasible for a part of patients. Inductive chemoimmunotherapy+chemoradiotherapy±surgery Chemoradiotherapy ±immunotherapy In this group, the patients were given 2 cycles of inductive therapy of cardonilizumab combined with chemotherapy, followed by concurrent chemoradiotherapy with two cycles of nab-paclitaxel and cisplatin plus radiotherapy of 50-50.4 Gy. After clinical evaluation, surgery was feasible for a part of patients.
- Primary Outcome Measures
Name Time Method Event-free survival 1-year Time from treatment initiation to locoregional or distant recurrence, or death from any cause.
- Secondary Outcome Measures
Name Time Method Adverse events 1-year In terms of adverse events of radiation, chemotherapy and immunotherapy
Distant metastasis free survival 1-year The 1-year rate was defined as the proportion of patients who did not have any distant metastasis from treatment initiation.
Locoregional recurrence free survival 1-year The 1-year rate was defined as the proportion of patients who did not have any locoregional recurrence from treatment initiation.
Overall survival 1-year The 1-year OS rate was defined as the proportion of patients who still alive within one year from treatment initiation.
Trial Locations
- Locations (3)
Anyang Cancer Hospital
🇨🇳Anyang, Henan, China
The First Affiliated Hospital of Xinxiang Medical University
🇨🇳Xinxiang, Henan, China
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)
🇨🇳Beijing, China