Safety and Efficacy of Sintilimab in Combination With Chemoradiothrapy Followed by D2 Surgical Resection in Patients With Advanced Gastric Cancer With Retroperitoneal Lymph Node Metastasis

August 23, 2021 updated by: Chen Li, Ruijin Hospital

Safety and Efficacy of Sintilimab in Combination With Albumin-Paclitaxel/Oxaliplatin/Capecitabine and Radiotherapy Followed by D2 Surgical Resection in Patients With Advanced Gastric Cancer With Retroperitoneal Lymph Node Metastasis: A Multiple Center Single Arm Trial

Gastric cancer with retroperitoneal lymph node metastasis was considered as unresectable, to improve these patients' prognosis, we designed systematic conversion therapy including immunotherapy and chemoradiotherapy. The purpose of this study is to estimate safety and efficacy of Sintilimab in combination with chemoradiothrapy followed by D2 surgical resection in patients with advanced gastric cancer with retroperitoneal lymph node metastasis.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Recruiting
        • Ruijin Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

  • Pathology confirmed Gastric/Gastricgastroesophageal junction adenocarcinoma;
  • Radiolgical imging including CT,PET-CT or MRI diagnosed as retroperitoneal metastasis.
  • Did not receive previous systemic treatment (chemotheray, radiotherapy or both) for advanced disease before.
  • ECOG PS 0-2.
  • Adequate organ and bone marrow functions and life expectancy ≥12 weeks.

Exclusion Criteria:

  • Distant metastases except retroperitoneal metastasis (liver, lung, peitoneal metastasis...);
  • HER2-positive status;
  • Suspicious active bleeding or gastriointestineal obstruction phenomenon and Has difficulty in swallow tablets and food;
  • Has received prior therapy with an anti-programmed death (PD)-1, anti-PD-L1, anti-PD L2 , anti-CD137,anti-CTLA-4 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor
  • Is currently participating in and receiving study therapy ,except those in the survival follow up period of an investigational agent study or non-interventional study .
  • Received systemic treatment with corticosteroids (> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 4 weeks of first dose. Inhaled or topical steroids ,adrenal replacement steroid doses and steroid of prevention allergic reaction of i.v. contrast agent are permitted in the absence of active autoimmune disease.
  • Known acute or chronic active hepatitis B infection (positive HBsAg and HBV DNA ≥ 200 IU/mL or ≥ 10^3 copies/mL positive) infection or acute or chronic active hepatitis C (HCV antibody positive and HCV RNA positive) infection.
  • Women who are pregnant or nursing.
  • Received a live vaccine within 4 weeks of the first dose of study medication or plan to receive live vaccine during study period.
  • Active, known or suspected autoimmune disease or has a history of the disease within the last 2 years (subjects with vitiligo, psoriasis, alopecia or Grave's disease, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or type I diabetes mellitus only requiring insulin replacement, but not required systemic treatment in the last 2 years, are permitted to enroll) .
  • Known primary immunodeficiency.
  • Known active tuberculosis.
  • Known history of allogeneic organ or allogeneic hemopoietic stem cell transplantation.
  • Known>=grade 3 allergy or hypersensitivity to Albumin-paclitaxel oxaliplatin, capecitabine or any monoclonal antibodies.
  • Human Immunodeficiency Virus (HIV) infection (HIV antibody positive).
  • Poorly controlled arterial hypertension (SBP ≥ 160mmHg or DBP ≥ 100 mmHg) with standard treatment .
  • Symptomatic congestive heart failure (New York Heart Association grade II-IV) or symptomatic, poorly controlled arrhythmia.
  • Prior arterial thromboembolism event, including myocardial infarction, unstable angina, stroke and transient ischemic attack, within 6 months of enrollment.
  • Active or poorly controlled severe infection.
  • History of gastrointestinal perforation and /or fistula within 6 months before enrollment.
  • Other acute or chronic diseases, mental illness, or abnormal laboratory test results that may lead to the following outcomes: increase the risk of participating in study or study drug administration, or interfere with the interpretation of the study results and considered by investigator as "NOT" eligible to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Sintilimab+ Albumin-Paclitaxel+Oxaliplatin +capecitabine+radiothrerapy+D2 Surgical Resection
Drug: Oxaliplatin
130 mg/m^2 Q3W on Day 1 by IV infusion
Drug: Capecitabine
1000 mg/m^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14
Drug: Sintilimab
200 mg Q3W on Day 1 by IV infusion
Other Names:
  • IBI308
Drug: Albumin-Paclitaxel
200 mg/m^2 Q3W on Day 1 by IV infusion
Radiation: Radiation
Radiotherapy for gastric lesions and high-risk areas of retroperitoneal lymph node before sugery, 45Gy*25.
Procedure: Radical gastric cancer surgery
Radical gastric cancer surgery with D2 lymph node dissection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1 year Progression Free Survival (PFS)
Time Frame: Approximately 3 years after the first participant is included
Approximately 3 years after the first participant is included

Secondary Outcome Measures

Outcome Measure
Time Frame
R0 surgical resection percentage
Time Frame: Approximately 2 years after the first participant is included
Approximately 2 years after the first participant is included
Operative conversion percentage
Time Frame: Approximately 2 years after the first participant is included
Approximately 2 years after the first participant is included
Overall survival (OS)
Time Frame: Approximately 4 years after the first participant is included
Approximately 4 years after the first participant is included
Number of participants experiencing clinical and laboratory adverse events (AEs)
Time Frame: Approximately 4 years after the first participant is included
Approximately 4 years after the first participant is included
Percentage of pathologic complete response(pCR)
Time Frame: Approximately 2 years after the first participant is included
Approximately 2 years after the first participant is included

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Potential biomarker to predict prognosis
Time Frame: Approximately 4 years after the first participant is included
PD-L1 CPS, EBV expression, Tumor Mutational Burden(TMB), MSI-H/dMMR
Approximately 4 years after the first participant is included

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ruijin Hospital

Investigators

  • Principal Investigator: Chen Li, PhD, Ruijin hospital affiliatted to Shanghai Jiaotong University school of medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 7, 2021

Primary Completion (ANTICIPATED)

August 1, 2023

Study Completion (ANTICIPATED)

August 1, 2024

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 10, 2021

First Posted (ACTUAL)

August 12, 2021

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dragon VIII

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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