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Tislelizumab Combined With Chemotherapy in First-line Treatment of AGC

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06034964
Recruitment Status : Active, not recruiting
First Posted : September 13, 2023
Last Update Posted : September 13, 2023
Sponsor:
Information provided by (Responsible Party):
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study Description
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Brief Summary:
This is a single-center, retrospective clinical study to evaluate the efficacy and safety of tislelizumab combined with first-line chemotherapy in the treatment of HER2-negative advanced gastric cancer.

Condition or disease Intervention/treatment
Tislelizumab Chemotherapy First-line Gastric Cancer Stage IV Drug: Tislelizumab

Detailed Description:
This study aims to include 60 HER-2 negative advanced gastric cancer patients who received first-line treatment with tislelizumab combined with chemotherapy in our hospital from November 1, 2020 to November 1, 2021. Clinicopathological data, blood tests and imaging data of the patients were collected. The primary endpoints evaluated were PFS and OS, and the secondary endpoints were ORR and safety. At the same time, ctDNA and peripheral cytokine status of patients as well as second-generation sequencing of tumor tissues at baseline were collected for the exploration of therapeutic efficacy related biomarkers.
Study Design
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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Retrospective Study of Tislelizumab Combined With Chemotherapy in First-line Treatment of HER2-negative Advanced Gastric Cancer
Actual Study Start Date : November 1, 2020
Actual Primary Completion Date : November 1, 2022
Estimated Study Completion Date : November 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Groups and Cohorts
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Intervention Details:
  • Drug: Tislelizumab
    Tislelizumab：200mg, iv, d1, 21 days per cycle, until disease progression or intolerable toxicity
    Other Name: BGB-A317

Outcome Measures
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Primary Outcome Measures :
  1. PFS [ Time Frame: 2 years ]
    Progression-free Survival

  2. OS [ Time Frame: 3 years ]
    Overall Survival


Secondary Outcome Measures :
  1. ORR [ Time Frame: 2 years ]
    Objective Remission Rate

  2. DCR [ Time Frame: 2 years ]
    Disease Control Rate

  3. DOR [ Time Frame: 2 years ]
    Duration of Remission

  4. Safety and Tolerability [ Time Frame: 2 years ]
    Incidence of Treatment-Emergent Adverse Events


Biospecimen Retention:   Samples With DNA
Blood sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
HER-2 negative, untreated patients with advanced gastric cancer.
Criteria

Inclusion Criteria:

  1. Patients with initially unresectable (locally advanced or metastatic) or postoperative recurrence of gastric adenocarcinoma or gastroesophageal junction adenocarcinoma confirmed by histopathology have not received any anti-tumor treatment for advanced gastric cancer in the past;
  2. Pathological immunohistochemistry or FISH detection of gastric cancer tissue indicates negative Her-2;
  3. Age range from 18 to 70 years old, regardless of gender;
  4. The distance between postoperative recurrence and the end of neoadjuvant/adjuvant chemotherapy is more than 6 months;
  5. If the patient experiences toxic side effects after receiving new adjuvant/adjuvant treatment, they need to recover from previous treatment toxic side effects to ≤ 1 level; According to the RECIST evaluation criteria, there should be at least one assessable lesion. Expected survival time ≥ 3 months;

7. ECOG score ≤ 2 points; 8. Main organ functions are basically normal, blood count (within 7 days): hemoglobin ≥ 90g/L, white blood cells ≥ 4.0 × 109/L, neutrophils ≥ 2.0 × 109/L, platelet ≥ 100.0 × 109/L. Total bilirubin 1.0 UNL, creatinine 1.0 × UNL, AST/ALT 2.5 UNL. Liver metastasis: ASAT/ALAT 5 UNL; 9. The electrocardiogram/cardiac function tests are basically normal.

Exclusion Criteria:

  1. Suffering from undifferentiated gastric cancer or squamous cell carcinoma of the gastroesophageal junction and other pathological types of malignant tumors;
  2. Have received anti-tumor treatment for gastric adenocarcinoma or adenocarcinoma at the junction of stomach and esophagus that can not be operated on for the first time or recur after operation, including but not limited to chemotherapy, Targeted therapy, immunotherapy, etc. (except for Thymosin and traditional Chinese medicine treatment);
  3. Patients with other primary malignant tumors other than gastric cancer, excluding cured skin Basal-cell carcinoma and cervical Carcinoma in situ;
  4. Patients with simple or combined brain metastasis;
  5. Has experienced gastrointestinal perforation or fistula within 6 months prior to enrollment;
  6. Patients who also suffer from other important organ diseases, including severe heart disease;
  7. Complications such as uncontrollable moderate to massive ascites, active gastrointestinal bleeding, gastrointestinal perforation, gastrointestinal obstruction, etc;
  8. Patients with chronic diseases such as hypertension, hyperglycemia, and COPD that are difficult to control;
  9. Those who require antibiotics for systemic anti infection, active hepatitis, active pulmonary tuberculosis, and other diseases.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06034964


Locations
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China
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Sponsors and Collaborators
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Investigators
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Principal Investigator: Lin Yang Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
More Information
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Responsible Party: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT06034964    
Other Study ID Numbers: NCC3221
First Posted: September 13, 2023    Key Record Dates
Last Update Posted: September 13, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cancer Institute and Hospital, Chinese Academy of Medical Sciences:
Tislelizumab
First-line
Gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Stomach Diseases
Tislelizumab
Antineoplastic Agents, Immunological
Antineoplastic Agents