Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

NCT06421376 | Recruiting Phase 2

• 1 other identifier: NCC4475
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Event-free survival

  Time from treatment initiation to locoregional or distant recurrence, or death from any cause.

  1-year

Secondary Outcomes (4)

• Overall survival

  1-year

• Adverse events

  1-year

• Locoregional recurrence free survival

  1-year

• Distant metastasis free survival

  1-year

Study Arms (1)

Inductive chemoimmunotherapy+chemoradiotherapy±surgery

EXPERIMENTAL

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.

Drug: Cardonilizumab; Radiation: Chemoradiotherapy ±immunotherapy; Procedure: Radical surgery

Interventions

Cardonilizumab DRUG

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

Inductive chemoimmunotherapy+chemoradiotherapy±surgery

Chemoradiotherapy ±immunotherapy 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

Inductive chemoimmunotherapy+chemoradiotherapy±surgery

Radical surgery 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.

Inductive chemoimmunotherapy+chemoradiotherapy±surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (3)

Anyang Cancer Hospital

Anyang, Henan, China

NOT YET RECRUITING

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, China

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, 100021, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Xin Wang

  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)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Wang, M.D.

CONTACT

+8601087787635; beryl_wx2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 20, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)