A Study of Camrelizumab As Consolidation Therapy After Radical Concurrent Chemoradiotherapy In Locally Advanced ESCC

Esophageal Cancer Clinical Trial

— ESCC  

Official title:

A Study of Camrelizumab As Consolidation Therapy After Radical Concurrent Chemoradiotherapy In Locally Advanced Esophageal Squamous Cell Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04286958
• Other study ID #: HRHB-CE001
• Status: Recruiting
• Phase: Phase 2
• Start date: April 22, 2020
• Est. completion date: March 1, 2023

Study information

• Verified date: December 2021
• Source: Hebei Medical University Fourth Hospital
• Contact: JUN WANG, Ph.D
• Phone: 13931182128
• Email: wangjunzr[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess efficacy and safety of patients who receive camrelizumab as consolidation therapy after radical concurrent chemoradiotherapy in locally advanced ESCC.

Description:

In this study, 40 patients with locally advanced ESCC will be enrolled. All patients who had received radical concurrent chemoradiotherapy were treated with camrelizumab.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 1, 2023
• Est. primary completion date: December 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age:18 to 75 years old;

2. Histology confirmed as esophageal squamous cell carcinoma;

3. T1bN+M0, T2-4N0-2M0 local progress period;

4. Have previously received radical concurrent chemoradiotherapy;

5. According to RECIST 1.1, at least one measurable lesion;

6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;

7. Expected survival period = 12 weeks;

8. Major organ function has to meet the following certeria:

1)For results of blood routine test HB=90g/L; ANC=1.5×109/L; PLT=80×109/L; 2)For results of blood biochemical test ALB=30g/L; ALT and AST<2.5×ULN; TBIL=1.5ULN; Serum creatinine =1.5ULN; 9. Left ventricular ejection fraction (LVEF) =50%; 10. Women of childbearing age must have contraceptive measures or have test pregnancy (serum or urine) enroll the study before 14 days, and the results must be negative, and take the methods of contraception during the test and the last to have drugs after 8 weeks. Men must be contraception or has sterilization surgery during the test and the last to have drugs after 8 weeks; 11. Participants were willing to join in this study, and written informed consent, good adherence, cooperate with the follow-up.

Exclusion Criteria:

1. Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);

2. The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, Hyperthyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);

3. Patients with other malignant tumors within 5 years (except for the treated skin basal cell carcinoma and cervical carcinoma in situ);

4. Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA =1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study ; 5.6 months before study drug administration, the following occurred: myocardial infarction, severe / unstable angina pectoris, grade III-IV cardiac insufficiency according to New York Heart Association(NYHA) criteria, uncontrolled arrhythmias (including QTcF interval male> 450 ms, female> 470 ms ,The QTcF interval is calculated using Fridericia formula), symptomatic congestive heart failure, cerebrovascular accidents (including transient ischemic attack or symptomatic pulmonary embolism);

6.Severe infections within 4 weeks before study drug administration (eg. Need intravenous drip antibiotics, antifungals or antivirals) or Unexplained fever>38.5? during screening visits or on the first scheduled day of dosing; 7.History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 8.Less than 4 weeks from the last clinical trial; 9.History of psychiatric drugs abuse and can't quit or patients with mental disorders; 10.The researchers think inappropriate.

Related Conditions & MeSH terms

• Esophageal Cancer

Intervention

Drug:
• Camrelizumab
Camrelizumab: 200 mg was given intravenously over a period of 30 minutes (no less than 20 minutes and no longer than 60 minutes)

Locations

Country	Name	City	State
China	Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Biomarkers	Relationship between tumor markers and efficacy in tumor tissues and peripheral blood (including but not limited to PD-L1, TMB, etc.)	up to 24 months
Primary	Progression free survival (PFS)	Baseline to measured date of progression or death from any cause	evaluated in 24 months since the treatment began
Secondary	Objective response rate (ORR)	Baseline to measured stable disease	tumor assessment every 6 weeks since the treatment began,up to 24 months
Secondary	Durarion of response (DOR)	From the first assessment to CR or PR to the first assessment to PD or death from any cause	tumor assessment every 6 weeks since the treatment began,up to 24 months
Secondary	Overall survival (OS)	Baseline to measured date of death from any cause	the first day of treatment to death or last survival confirm date,up to 24 months
Secondary	Adverse events	Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03. The number of Participants with adverse events will be recorded at each treatment visit	up to 24 months