SBRT Combined With AK104 to Treatment Relapsed or Metastatic ESCC

NCT05732662 | Not Yet Recruiting Phase 2

• 1 other identifier: SBRTAK104
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

The entire treatment process is divided into two phases: Phase I SBRT combined with PD-1/CTLA-4 bispecific antibody (AK104) and Phase II AK104 single-agent maintenance therapy.

Conditions

Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Keywords

SBRT, AK104

Outcome Measures

Primary Outcomes (1)

• ORR

  objective response rate

  Up to 3 years

Secondary Outcomes (3)

• PFS

  Up to 3 years

• OS

  Up to 3 years

• Treatment Related Severe Adverse Effects

  Up to 3 years

Study Arms (1)

SBRT combined with PD-1/CTLA-4 dual antibody

EXPERIMENTAL

Radiation: SBRT; Drug: Cadonilimab

Interventions

SBRT RADIATION

24-50Gy/8-12.5Gy/3-4f

SBRT combined with PD-1/CTLA-4 dual antibody

Cadonilimab DRUG

10 mg/kg,q3w

SBRT combined with PD-1/CTLA-4 dual antibody

Eligibility Criteria

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

You may qualify if:

• \. age ≥ 18 years. 2. patients enrolled must be eligible for PD-1 treatment-naïve patients with recurrent or metastatic advanced esophageal squamous carcinoma with definite measurable recurrent or metastatic lesions.
• \. have at least 2 or more clearly measurable lesions (maximum diameter of lesions≥1 cm and shortest diameter of ≥1.5 cm of lymph nodes according to RECIST v1.1), at least one of which is feasible for radiation therapy).
• \. no congestive heart failure, unstable angina, or unstable arrhythmia within the last 6 months.
• \. patient activity status score of 0-3 on the Eastern Cooperative Oncology Group (ECOG) scale with a life expectancy assessment of ≥ 3 months.
• \. no previous serious abnormalities of hematopoietic, cardiac, pulmonary, hepatic, or renal function and immunodeficiency.
• \. absolute T-lymphocyte values ≥ 0.5 times the lower limit of normal and neutrophils ≥ 2.0 × 109/L; AST and ALT ≤ 3.0 times the upper limit of normal (≤ 5.0 times the upper limit of normal for hepatocellular carcinoma/metastatic liver cancer); and creatinine ≤ 3.0 times the upper limit of normal, 1 week before enrollment.
• \. patients must have the ability to understand and voluntarily sign the informed consent form.

You may not qualify if:

• \. pregnant gestational or lactating women. 2. those with a history of other malignant diseases in the last 5 years. 3. persons with a history of uncontrolled epilepsy, central nervous system disease, or psychiatric disorder whose clinical severity, as judged by the investigator, may prevent signing an informed consent form or affect patient compliance with medication.
• \. clinically significant (i.e., active) heart disease such as symptomatic coronary artery disease, New York Heart Association (NYHA) class II or worse congestive heart failure or severe arrhythmias requiring pharmacologic intervention, or a history of myocardial infarction within the last 12 months.
• \. organ transplantation requiring immunosuppressive therapy. 6. Significant active infection or, in the judgment of the investigator, significant hematologic, renal, metabolic, gastrointestinal, endocrine dysfunction or metabolic disorder, or other serious uncontrolled concomitant disease.
• \. hypersensitivity to any investigational drug component. 8. have a history of immunodeficiency, including testing positive for HIV or having other acquired or congenital immunodeficiency diseases, or a history of organ transplantation, or other immune-related diseases requiring long-term oral hormone therapy.
• \. those who are undergoing acute or chronic TB infection (patients with positive T-spot test and suspicious TB foci on chest radiograph).
• \. other conditions that the investigator considers unsuitable for enrollment.

Sponsors & Collaborators

• The First People's Hospital of Changzhou: lead

MeSH Terms

Conditions

Recurrence; Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Central Study Contacts

Wendong Gu, Doctor

CONTACT

13861220022; guwendong1415@czfph.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: chief physician

Study Record Dates

• First Submitted: February 8, 2023
• First Posted: February 17, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2023

Record last verified: 2023-02