Clinical trial NCT04286958: A Study of Camrelizumab As Consolidation Therapy After Radical Concurrent Chemoradiotherapy In Locally Advanced ESCC
Official title: A Study of Camrelizumab As Consolidation Therapy After Radical Concurrent Chemoradiotherapy In Locally Advanced Esophageal Squamous Cell Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer
Lead sponsor: Hebei Medical University Fourth Hospital
Sponsor class: OTHER
First posted: 2020-02-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: evaluated in 24 months since the treatment began
Secondary outcomes:
measure: Objective response rate (ORR)
timeFrame: tumor assessment every 6 weeks since the treatment began，up to 24 months
measure: Durarion of response (DOR)
timeFrame: tumor assessment every 6 weeks since the treatment began，up to 24 months
measure: Overall survival (OS)
timeFrame: the first day of treatment to death or last survival confirm date,up to 24 months
measure: Adverse events
timeFrame: up to 24 months
Other outcomes:
measure: Biomarkers
timeFrame: up to 24 months
Locations:
city: Shijiazhuang
country: China
facility: Fourth Hospital of Hebei Medical University
state: Hebei
Study officials:
References: