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

NCT04286958 | Unknown Phase 2

• 1 other identifier: HRHB-CE001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Baseline to measured date of progression or death from any cause

  evaluated in 24 months since the treatment began

Secondary Outcomes (4)

• Objective response rate (ORR)

  tumor assessment every 6 weeks since the treatment began，up to 24 months

• Durarion of response (DOR)

  tumor assessment every 6 weeks since the treatment began，up to 24 months

• Overall survival (OS)

  the first day of treatment to death or last survival confirm date,up to 24 months

• Adverse events

  up to 24 months

Other Outcomes (1)

• Biomarkers

  up to 24 months

Study Arms (1)

Camrelizumab

EXPERIMENTAL

All patients who had received radical concurrent chemoradiotherapy were treated with camrelizumab.

Drug: Camrelizumab

Interventions

Camrelizumab DRUG

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

Camrelizumab

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age:18 to 75 years old;
• Histology confirmed as esophageal squamous cell carcinoma;
• T1bN+M0, T2-4N0-2M0 local progress period;
• Have previously received radical concurrent chemoradiotherapy;
• According to RECIST 1.1, at least one measurable lesion;
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
• Expected survival period ≥ 12 weeks;
• Major organ function has to meet the following certeria:
• )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.

You may not qualify if:

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

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

camrelizumab

Condition Hierarchy (Ancestors)

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

Central Study Contacts

JUN WANG, Ph.D

CONTACT

13931182128; wangjunzr@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: Director

Study Record Dates

• First Submitted: February 25, 2020
• First Posted: February 27, 2020
• Study Start: April 22, 2020
• Primary Completion: December 22, 2022
• Study Completion: March 1, 2023
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

CN (1)