The Purpose of This Study is to Evaluate the Efficacy and Safety of Sintilimab in Combination With Xelox as Neoadjuvant Therapy for Patients With Resectable Locally Advanced Gastric or Gastroesophageal Adenocarcinoma.

NCT04065282 | Unknown Phase 2

• 1 other identifier: CIBI308Y030
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Sintilimab in Combination With Capecitabine and Oxaliplatin (XELOX) as Neoadjuvant Therapy in patients With Resectable Locally Advanced Gastric Cancer

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Pathological complete response rate (pCR)

  evaluate pathological complete response rate of primary tumor and locally metastatic lymph nodes after 3 cycles of neoadjuvant therapy.

  after surgical resection (up to 12 weeks after first dosing)

Secondary Outcomes (5)

• Objective response rate (ORR)

  9 to 12 weeks

• Tumor regression grade (TRG)

  after surgical resection (up to 12 weeks after first dosing)

• Disease free survival (DFS)

  every 90 days after resection, up to 2 years

• 1-year overall survival rate

  1 years

• 2-year overall survival rate

  2 years

Other Outcomes (4)

• Overall survival (OS)

  up to 5 years

• PD-L1 expression, tumor infiltrating lymphocytes (TIL), etc.

  after surgical resection (up to 12 weeks after first dosing)

• Cytokine (IL-6)

  up to 12 weeks after first dosing

Study Arms (1)

neoadjuvant therapy with Sintilimab plus Xelox

EXPERIMENTAL

3 cycles of neoadjuvant therapy: Sintilimab iv d1 Q3W, Oxaliplatin 130mg/m2 iv d1 Q3W, and Capecitabine 1000mg/m2 po Bid d1-14 Q3W

Drug: Sintilimab; Drug: Oxaliplatin; Drug: Capecitabine

Interventions

Sintilimab DRUG

3 cycles before radical surgery

Also known as: IBI308

neoadjuvant therapy with Sintilimab plus Xelox

Oxaliplatin DRUG

85mg/m2 Q3W, 3 cycles perioperation

neoadjuvant therapy with Sintilimab plus Xelox

Capecitabine DRUG

1000mg/m2 bid po D1\~14 Q3W, 3 cycles perioperation

neoadjuvant therapy with Sintilimab plus Xelox

Eligibility Criteria

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

You may qualify if:

• Histologically proven adenocarcinoma of the stomach.
• The primary tumor locates at stomach or esophagogastroesophageal ic junction.
• Clinical T3-4NxM0 disease, confirmed by enhanced contrast abdominal computed tomography (CT) or magnetic resonance imaging (MRI).
• At least one measurable lesion.
• Resectable gastric or gastroesophageal cancer, judged by surgeons in this studyEligible and reasonably suitable for potentially curative resection
• ECOG performance status 0-1.
• Adequate organ function for chemotherapy and surgical treatment, as evaluated by laboratory tests.
• Written (signed) informed consent.
• Good compliance with the study procedures, including lab and auxiliary examination and treatment.
• Agree to use an approved contraceptive method during the treatment period, until 120 days after last dose of Sintilimab or 180 days after last dose of chemotherapy.

You may not qualify if:

• Unsectable primary tumor or any distant metastatic disease.
• Received any anti-cancer therapy for this disease, including radiation therapies, chemotherapies, immunotherapies, and Chinese traditional herb therapies.
• Clinical T1-2N0M0 disease, confirmed by CT/MRI or endoscopic ultrasonography.
• Active autoimmune disease or history of refractory autoimmune disease.
• History of any other malignant tumor within 2 years, excluding cured local tumor, such as resected skin basal cell or squamous cell carcinoma, superficial bladder cancer, cervical carcinoma in situ, or ductal carcinoma in situ (DCIS).
• History of gastrointestinal hemorrhage within 2 weeks before enrollment or patients with a high risk of hemorrhage.
• History of gastrointestinal perforation within 6 months before enrollment.
• Gastrointestinal obstruction, gastrointestinal dysfunction, or malabsorption syndrome that may affect the absorption of Capecitabine.
• Weight loss is greater than 20% within 2 months before enrollment.
• History of severe pulmonary disease, including but not limited to interstitial pulmonary disease, noninfectious pneumonitis, pulmonary fibrosis, acute pulmonary disease
• Uncontrolled systematic disease, including diabetes mellitus, hypertension, etc.
• Severe chronic or active infectious disease that needs systematic antibiotics, antifungal, or antiviral therapies.
• Untreated chronic hepatitis B, serum HBV DNA load higher than the lower threshold of the test, or HCV RNA positive.
• With any cardiovascular risk factors as follow:
• History of angina within 28 days before enrollment, defined as moderate pain affecting daily activities;

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

First Affiliated Hospital of Zhejiang University

Zhejiang, China

RECRUITING

Related Publications (1)

• Jiang H, Yu X, Li N, Kong M, Ma Z, Zhou D, Wang W, Wang H, Wang H, He K, Li Z, Lu Y, Zhang J, Zhao K, Zhang Y, Xu N, Li Z, Liu Y, Wang Y, Wang Y, Teng L. Efficacy and safety of neoadjuvant sintilimab, oxaliplatin and capecitabine in patients with locally advanced, resectable gastric or gastroesophageal junction adenocarcinoma: early results of a phase 2 study. J Immunother Cancer. 2022 Mar;10(3):e003635. doi: 10.1136/jitc-2021-003635.

  PMID: 35296556 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

sintilimab; Oxaliplatin; Capecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Haiping Jiang, PhD

CONTACT

0571-87235896; jianghaiping75@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: Associate cheif physician

Model Details: neoadjuvant chemotherapy sintilimab plus XELOX

Study Record Dates

• First Submitted: August 15, 2019
• First Posted: August 22, 2019
• Study Start: August 6, 2019
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2022
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

CN (1)