A Phase Ⅱ Trials of Sintilimab as Consolidation Therapy After Radical Concurrent Chemoradiotherapy in Locally Advanced Unresectable ESCC

NCT04514835 | Unknown Phase 2

• 1 other identifier: IBI308-01
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe and evaluate the efficacy and safety of Sintilimab for Consolidation Therapy After Radical Concurrent Chemoradiotherapy for Locally Advanced Unresectable Esophageal Squamous Cell Carcinoma

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Progression-free survival（PFS）

  Evaluation of anti-PD-1 antibody Sintilimab for progression-free survival in patients with locally advanced unresectable esophageal squamous cell carcinoma who did not develop disease after radical concurrent chemoradiotherapy

  up to 1 year

Secondary Outcomes (1)

• Objective Response Rate，ORR

  At time of surgery

Other Outcomes (2)

• Overall survival, OS

  At time of surgery

• Exploratory analysis of biomarkers for predicting efficacy

  At time of surgery

Study Arms (1)

Cisplatin+Capecitabine+Sintilimab

EXPERIMENTAL

Cisplatin+Capecitabine+Sintilimab

Drug: Cisplatin+Capecitabine+Sintilimab

Interventions

Cisplatin+Capecitabine+Sintilimab DRUG

The first stage:concurrent chemoradiotherapy，cisplatin，25-30mg/m2 ivgtt d1;capecitabine,800mg/m2, bid d1-5，qw，5weeks;concurrent radiotherapy,1.8-2Gy/d，5d/W，50-50.4Gy. second stage:Sintilimab, 200mg,q3w, a total of 3 times，Each infusion lasted for 30-60 min until disease progression or intolerable toxicity, with a maximum duration of no more than 12 months.

Cisplatin+Capecitabine+Sintilimab

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 18-75 years old, both men and women; 2. Histology confirmed as esophageal squamous cell carcinoma; 3. T1bN+M0, T2-T4aN0-2M0 locally advanced stage； 4. Tissue samples should be provided for biomarker analysis, and the newly obtained tissues should be selected. Patients who cannot provide newly obtained tissues can provide 5-8. pieces of 5-um thick paraffin sections; 5. ECOG: 0\~1; 6. Expected survival period ≥ 12 weeks; 7. The main organs function normally, that is, the following criteria are met:
• Blood routine examination:
• HB≥90g/L;
• ANC ≥ 1.5 × 109 / L;
• PLT ≥ 80 × 109 / L;
• Biochemical examination:
• ALB ≥ 30g / L;b.ALT and AST ≤ 2.5ULN; if there is liver metastasis, ALT and AST ≤ 5ULN;c.TBIL ≤ 1.5ULN;d.plasma Cr ≤ 1.5ULN or creatinine clearance (CCr) ≥ 60ml / min; 8.Doppler ultrasound assessment: left ventricular ejection fraction (LVEF) ≥ normal low limit (50%); 9. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy test within 7 days prior to study enrollment And must be non-lactating patients; males should agree to patients who must use contraception during the study period and within 6 months after the end of the study period; 10. Subjects voluntarily joined the study, signed informed consent, and were well-adhered to follow-up.

You may not qualify if:

• Those who are allergic to or sensitive to capecitabine and cisplatin or metabolic disorders;
• 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);
• The patient is using immunosuppressive agents or systemic hormonal therapy for immunosuppressive purposes (dose\> 10 mg/day of prednisone or other therapeutic hormones) and continues to be used for 2 weeks prior to enrollment;
• contraindications to radiotherapy;
• Patients with any severe and/or uncontrolled diseases:Patients with unsatisfactory blood pressure control (systolic blood pressure ≥150mmHg or diastolic blood pressure ≥100 mmHg); myocardial ischemia or myocardial infarction with grade I or above, arrhythmia (including QT interval ≥ 480ms) and grade I cardiac insufficiency;
• Active or uncontrolled serious infections;
• Liver diseases such as decompensated liver disease, active hepatitis B (HBV-DNA ≥ 104 copies/ml or 2000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method);
• Urine routine indicates that urine protein ≥ ++, and confirmed 24-hour urine protein quantitation\> 1.0g;
• The patients whose imaging showed that the tumor had invaded the important vessels or the tumor was likely to invade the important vessels and cause fatal hemorrhage during the follow-up study;
• Pregnant or lactating women;
• Patients with other malignancies within 5 years (except for basal cell carcinoma and cervical carcinoma in situ) that have been cured;
• Patients with a history of psychotropic substance abuse who are unable to quit or have a mental disorder;
• Patients who have participated in other drug clinical trials within four weeks;
• At the discretion of the investigator, there are patients with serious concomitant disease that compromises patient safety or affects the patient's completion of the study;

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, 450001, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Feng Wang

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Wang

CONTACT

13938244776; fengw010@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: DOCTOR

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 17, 2020
• Study Start: December 1, 2021
• Primary Completion: January 31, 2022
• Study Completion: January 31, 2023
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

CN (1)