Induction Chemoimmunotherapy Combined With Chemoradiotherapy in Esophageal Cancer

Surgery Clinical Trial

Official title:

Efficacy and Safety of Inductive Chemoimmunotherapy Followed by Chemoradiotherapy With or Without Surgery in Locally Advanced Esophageal Squamous Cell Cancer: a Single-arm, Prospective, Phase II Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06421376
• Other study ID #: NCC4475
• Status: Recruiting
• Phase: Phase 2
• Start date: May 1, 2024
• Est. completion date: December 31, 2027

Study information

• Verified date: May 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Xin Wang, M.D.
• Phone: +861013311583220
• Email: beryl_wx2000[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chemoradiotherapy
• Esophageal Cancer
• Esophageal Neoplasms
• Immunotherapy
• Induction Therapy
• Surgery

Intervention

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

Radiation:
• Chemoradiotherapy ±immunotherapy
Chemoradiotherapy ± immunotherapy: PTV: 50-50.4Gy/1.8-2Gy/25-28fractions ?nab-paclitaxel 100mg+cisplatin 25mg/ m2, d1, every 7 days for 3-5 weeks ?Cardonilizumab 10mg/kg,ivgtt,3 weeks per cycle for 2 cycles

Procedure:
• 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.

Locations

Country	Name	City	State
China	Anyang Cancer Hospital	Anyang	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	The First Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	Time from treatment initiation to locoregional or distant recurrence, or death from any cause.	1-year
Secondary	Overall survival	The 1-year OS rate was defined as the proportion of patients who still alive within one year from treatment initiation.	1-year
Secondary	Adverse events	In terms of adverse events of radiation, chemotherapy and immunotherapy	1-year
Secondary	Locoregional recurrence free survival	The 1-year rate was defined as the proportion of patients who did not have any locoregional recurrence from treatment initiation.	1-year
Secondary	Distant metastasis free survival	The 1-year rate was defined as the proportion of patients who did not have any distant metastasis from treatment initiation.	1-year