Tislelizumab Combined With Chemotherapy in First-line Treatment of AGC

NCT06034964 | Unknown FDA Drug

• 1 other identifier: NCC3221
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Tislelizumab; Chemotherapy; First-line; Gastric Cancer Stage IV

Keywords

Tislelizumab; First-line; Gastric cancer

Outcome Measures

Primary Outcomes (2)

• PFS

  Progression-free Survival

  2 years

• OS

  Overall Survival

  3 years

Secondary Outcomes (4)

• ORR

  2 years

• DCR

  2 years

• DOR

  2 years

• Safety and Tolerability

  2 years

Interventions

Tislelizumab DRUG

Tislelizumab：200mg, iv, d1, 21 days per cycle, until disease progression or intolerable toxicity

Also known as: BGB-A317

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

HER-2 negative, untreated patients with advanced gastric cancer.

You may qualify if:

• 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;
• Pathological immunohistochemistry or FISH detection of gastric cancer tissue indicates negative Her-2;
• Age range from 18 to 70 years old, regardless of gender;
• The distance between postoperative recurrence and the end of neoadjuvant/adjuvant chemotherapy is more than 6 months;
• 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;
• \. 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.

You may not qualify if:

• Suffering from undifferentiated gastric cancer or squamous cell carcinoma of the gastroesophageal junction and other pathological types of malignant tumors;
• 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);
• Patients with other primary malignant tumors other than gastric cancer, excluding cured skin Basal-cell carcinoma and cervical Carcinoma in situ;
• Patients with simple or combined brain metastasis;
• Has experienced gastrointestinal perforation or fistula within 6 months prior to enrollment;
• Patients who also suffer from other important organ diseases, including severe heart disease;
• Complications such as uncontrollable moderate to massive ascites, active gastrointestinal bleeding, gastrointestinal perforation, gastrointestinal obstruction, etc;
• Patients with chronic diseases such as hypertension, hyperglycemia, and COPD that are difficult to control;
• Those who require antibiotics for systemic anti infection, active hepatitis, active pulmonary tuberculosis, and other diseases.

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

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

Study Officials

• Lin Yang

  Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: November 1, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-08

Locations

CN (1)