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

NCT ID: NCT05002686

Last Updated: 2021-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-07
• Study Completion Date: 2024-08-01

Brief Summary

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sintilimab+ Albumin-Paclitaxel+Oxaliplatin +capecitabine+radiothrerapy+D2 Surgical Resection

Group Type: EXPERIMENTAL

Sintilimab

Intervention Type: DRUG

200 mg Q3W on Day 1 by IV infusion

Albumin-Paclitaxel

Intervention Type: DRUG

200 mg/m\^2 Q3W on Day 1 by IV infusion

Capecitabine

Intervention Type: DRUG

1000 mg/m\^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14

Oxaliplatin

Intervention Type: DRUG

130 mg/m\^2 Q3W on Day 1 by IV infusion

Radiation

Intervention Type: RADIATION

Radiotherapy for gastric lesions and high-risk areas of retroperitoneal lymph node before sugery, 45Gy\*25.

Radical gastric cancer surgery

Intervention Type: PROCEDURE

Radical gastric cancer surgery with D2 lymph node dissection

Interventions

Sintilimab

200 mg Q3W on Day 1 by IV infusion

Intervention Type: DRUG

Albumin-Paclitaxel

200 mg/m\^2 Q3W on Day 1 by IV infusion

Intervention Type: DRUG

Capecitabine

1000 mg/m\^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14

Intervention Type: DRUG

Oxaliplatin

130 mg/m\^2 Q3W on Day 1 by IV infusion

Intervention Type: DRUG

Radiation

Radiotherapy for gastric lesions and high-risk areas of retroperitoneal lymph node before sugery, 45Gy\*25.

Intervention Type: RADIATION

Radical gastric cancer surgery

Radical gastric cancer surgery with D2 lymph node dissection

Intervention Type: PROCEDURE

Other Intervention Names

IBI308

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen Li

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chen Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin hospital affiliatted to Shanghai Jiaotong University school of medicine

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Changyu He, PhD

Role: CONTACT

hechangyu.2008@163.com

8618817821339

Facility Contacts

Chen Li, PhD, MD

Role: primary

leedoctor@sina.com

8602164370045

Other Identifiers

Dragon VIII

Identifier Type: -

Identifier Source: org_study_id