Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

NCT ID: NCT06421376

Last Updated: 2025-05-30

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2027-12-31

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.

Conditions

Esophageal Cancer; Immunotherapy; Induction Therapy; Chemoradiotherapy; Surgery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inductive chemoimmunotherapy+chemoradiotherapy±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.

Group Type: EXPERIMENTAL

Cardonilizumab

Intervention Type: DRUG

Two cycles of Inductive therapy： nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles

Chemoradiotherapy ±immunotherapy

Intervention Type: RADIATION

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

Radical surgery

Intervention Type: PROCEDURE

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.

Interventions

Cardonilizumab

Two cycles of Inductive therapy： nab-paclitaxel 250mg/ m2+cisplatin 75mg/ m2+Cardonilizumab 10mg/kg，ivgtt，3 weeks per cycle for 2 cycles

Intervention Type: DRUG

Chemoradiotherapy ±immunotherapy

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

Intervention Type: RADIATION

Radical surgery

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Jianjun Qin

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xin Wang

Role: PRINCIPAL_INVESTIGATOR

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)

Locations

Anyang Cancer Hospital

Anyang, Henan, China

Site Status: NOT_YET_RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

Site Status: NOT_YET_RECRUITING

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

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Wang, M.D.

Role: CONTACT

beryl_wx2000@163.com

+8601087787635

Facility Contacts

Xiaomin Wang, M.D.

Role: primary

Xiaomei Liu, M.D.

Role: primary

Xin Wang, MD

Role: primary

beryl_wx2000@163.com

+8601087787635

Other Identifiers

NCC4475

Identifier Type: -

Identifier Source: org_study_id