The Neoadjuvant Treatment of Locally Advanced Thoracic Esophageal Squamous Cell Carcinoma.

A Single-arm, Phase II Study of Camrelizumab Combined With S-1 Maintenance After First-Line Induction Chemotherapy in Patients With HER2 Negative Advanced Gastric Cancer

In this study, We investigated the efficacy and safty of camrelizumab combined with S-1 maintenance after first-line induction chemotherapy for GC. Patients without progressive disease after 4-6 weeks of first-line chemotherapy with SOX will be treated with camrelizumab combined with S-1.

Study Overview

• Status: Recruiting
• Conditions: Efficacy and Safty of Camrelizumab Plus S-1 Maintenance After First-line Induction Chemotherapy for GC
• Intervention / Treatment: Drug: Camrelizumab+S-1

• Study Type: Interventional
• Enrollment (Anticipated): 42
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100032
      • Recruiting
      • Lin Zhao
      • Contact: Lin Zhao, PhD; Phone Number: 010-69158754; Email: wz20010727@aliyun.com

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. Male or female subjects aged from 18 to 75 years old;
2. Subjects with histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastro-esophageal junction (GEJ);
3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry;
4. Disease must be measurable by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1);
5. Estimated life expectancy of more than 3 months;
6. Adequate haematological, hepatic and renal functions defined by the protocol;
7. Negative blood pregnancy test at Screening for women of childbearing potential; Highly effective contraception for both male and female subjects if the risk of conception exists;

Exclusion Criteria:

1. Concurrent anticancer treatment such as chemotherapy, radiotherapy, targeted or immunotherapy;
2. Tumor shown to be human epidermal growth factor 2 plus (HER2+);
3. Previous malignant disease (other than gastric cancer) within the last 5 years with the exception of basal or squamous cell carcinoma of the skin or carcinoma in situ (bladder, cervical, colorectal, breast);
4. Severe infection (e.g. need for intravenous antibiotics, antifungal or antiviral drugs) occurred within 4 weeks before the first administration, or fever (>38.5%) of unknown reason occurred during the screening period/before the first administration；
5. Any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (can be included after hormone replacement therapy)); The subjects with childhood asthma who had been completely relieved and did not need any intervention or vitiligo in adulthood could be included, but the subjects who needed bronchodilator for medical intervention could not be included;
6. Patients with congenital or acquired immune deficiency, such as human immunodeficiency virus (HIV) infection, active hepatitis B (HBV DNA ≥ 500 IU / ml), hepatitis C (HCV antibody positive and HCV-RNA higher than the detection limit of the analytical method), or co infection of hepatitis B and hepatitis C;
7. Used immunosuppressive drugs within 14 days before the first dose of study drug, excluding nasal and inhaled corticosteroids or physiological doses of systemic corticosteroids;
8. Accination with live or live/attenuated viruses within 28 days of the first dose of camrelizumab and while on trial is prohibited except for administration of inactivated vaccines;
9. History of uncontrolled intercurrent illness including hypertension, active infection, diabetes or cardiac diseases or symptoms;
10. Prior organ transplantation, including allogeneic stem-cell transplantation； Other protocol-defined inclusion/exclusion criteria could apply.

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+S-1	Drug: Camrelizumab+S-1; Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS)	PFS is defined as time (in months) from date of randomization to the date of the first documentation of objective progressive disease (PD) or death due to any cause in the absence of documented PD (whichever occurs first). PFS will be determined according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) based on investigator response assessment.	From the start of randomization to a minimum of 42 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0	TEAEs will be defined as the adverse events (AEs) that occur between first dose of study drug administration and 28 days after the last dose of study drug administration that were absent before treatment or that worsened relative to pretreatment state.	From the the first dose of study drug administration up to 28 days after the last dose of study drug administration, assessed up to 3.5 years
Objective Response Rate（ORR）	Assess ORR, defined as Investigator-assessed CR + PR, per RECIST 1.1.	From the start of randomization to a minimum of 42 months
Disease Control Rate (DCR)	Percentage of patients with CR/PR/SD in the number of patients that whose tumour can be evaluated.	Time Frame: From the start of randomization to a minimum of 42 months
Overall Survival（OS）	OS is defined as the time (in months) from randomization to the date of death, regardless of the actual cause of the subject's death.	From the start of randomization to a minimum of 42 months

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 24, 2021
• Primary Completion (Anticipated): December 24, 2025
• Study Completion (Anticipated): January 24, 2026

Study Registration Dates

• First Submitted: December 24, 2021
• First Submitted That Met QC Criteria: December 24, 2021
• First Posted (Actual): December 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 24, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: MA-GC-Ⅱ-09

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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