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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Drug: Camrelizumab

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: JUN WANG, Ph.D; Phone Number: 13931182128; Email: wangjunzr@163.com

Study Locations

• China
  • Hebei
    • Shijiazhuang, Hebei, China
      • Recruiting
      • Fourth Hospital of Hebei Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Camrelizumab; All patients who had received radical concurrent chemoradiotherapy were treated with camrelizumab.	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression free survival (PFS)	Baseline to measured date of progression or death from any cause	evaluated in 24 months since the treatment began

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective response rate (ORR)	Baseline to measured stable disease	tumor assessment every 6 weeks since the treatment began，up to 24 months
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hebei Medical University Fourth Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Anticipated): December 22, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: February 25, 2020
• First Posted (Actual): February 27, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: HRHB-CE001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No