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

NCT05002686 | Unknown Phase 2

• 1 other identifier: Dragon VIII
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

retroperitoneal lymph node metastasis; chemoradiotherapy; surgical resection

Outcome Measures

Primary Outcomes (1)

• 1 year Progression Free Survival (PFS)

  Approximately 3 years after the first participant is included

Secondary Outcomes (5)

• R0 surgical resection percentage

  Approximately 2 years after the first participant is included

• Operative conversion percentage

  Approximately 2 years after the first participant is included

• Overall survival (OS)

  Approximately 4 years after the first participant is included

• Number of participants experiencing clinical and laboratory adverse events (AEs)

  Approximately 4 years after the first participant is included

• Percentage of pathologic complete response(pCR)

  Approximately 2 years after the first participant is included

Other Outcomes (1)

• Potential biomarker to predict prognosis

  Approximately 4 years after the first participant is included

Study Arms (1)

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

EXPERIMENTAL

Drug: Sintilimab; Drug: Albumin-Paclitaxel; Drug: Capecitabine; Drug: Oxaliplatin; Radiation: Radiation; Procedure: Radical gastric cancer surgery

Interventions

Sintilimab DRUG

200 mg Q3W on Day 1 by IV infusion

Also known as: IBI308

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

Albumin-Paclitaxel DRUG

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

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

Capecitabine DRUG

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

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

Oxaliplatin DRUG

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

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

Radiation RADIATION

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

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

Radical gastric cancer surgery PROCEDURE

Radical gastric cancer surgery with D2 lymph node dissection

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; Capecitabine; Oxaliplatin; Radiation

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals; Physical Phenomena

Study Officials

• Chen Li, PhD

  Ruijin hospital affiliatted to Shanghai Jiaotong University school of medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Changyu He, PhD

CONTACT

8618817821339; hechangyu.2008@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: Chief physician

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 12, 2021
• Study Start: August 7, 2021
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: August 24, 2021

Record last verified: 2021-08

Locations

CN (1)