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Trial Title:
Tislelizumab Combined With XELOX as Neoadjuvant Therapy for G/GEJ Adenocarcinoma
NCT ID:
NCT05507658
Condition:
Locally Advanced Gastric Adenocarcinoma
Conditions: Official terms:
Adenocarcinoma
Capecitabine
Oxaliplatin
Tislelizumab
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Tislelizumab combined with Oxaliplatin and Capecitabine
Description:
Drugs:
1. Tistelizumab 200mg, iv.gtt, D1, Q3W;
2. Chemotherapy (XELOX) : oxaliplatin (130 mg/m2), iv.gtt, D1, Q3W; Capecitabine
(1000mg/m2), P.O.B.I.D., D1-D14, Q3W.
Neoadjuvant therapy:
1. Tislelizumab combined with XELOX, Q3W, for 2~3 cycles;
2. D2 radical gastrectomy after neoadjuvant therapy.
Adjuvant therapy:
1. From 4 to 8 weeks after surgery, the treatment dose was the same as above;
2. Patients who achieved MPR and non-MPR on pathological evaluation were treated with
tirelizumab +XELOX 3~8 cycles;
3. Tumor evaluation performed every 3 cycles;
4. The maximum duration of adjuvant therapy was not more than 8 cycles.
Arm group label:
Tislelizumab combined with XELOX
Summary:
The effective treatment of G/GEJ adenocarcinoma has always been a research hotspot in
academia. In recent years, mainstream studies have shown that the treatment mode of G/GEJ
adenocarcinoma has changed from single surgery mode in the past, to multi-disciplinary
comprehensive treatment mode for now, which is based on surgery. Several studies indicate
that for most late-stage G/GEJ adenocarcinoma, the neoadjuvant treatment model can
further enhance the survival rates and prognosis of patients, compared with the
combination of standard radical resection and postoperative adjuvant chemotherapy.
According to The Chinese Society of Clinical Oncology (CSCO): clinical guidelines for the
diagnosis and treatment of gastric cancer (Wang et al , 2021), neoadjuvant therapy and
adjuvant therapy are recommended for patients with G/GEJ adenocarcinoma. However, there
is still a lack of unified standards and norms for precise preoperative staging of
gastric cancer, applicable population of neoadjuvant along with adjuvant therapy, and the
selection of treatment regimens. Therefore, this project is aimed to carry out a
single-arm, open-label, phase II clinical trial to administer tirelizumab plus XELOX for
neoadjuvant management of patients diagnosed with resectable gastroesophageal junction or
stomach cancer, and further explore the safety and therapeutic effect of chemotherapy
together with tirelizumab in the neoadjuvant period of G/GEJ adenocarcinoma, eventually,
providing a new option for the neoadjuvant treatment of G/GEJ adenocarcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent;
2. Aged 18-80 (including 18 and 80), both sexes;
3. ECOG score ≤1;
4. Biopsy histologically confirmed adenocarcinoma (including Lauren grade);
5. cT3-4a N+ M0 G/GEJ adenocarcinoma confirmed by basic ultrasound gastroscopy,
enhanced CT (PET/CT), MRI or diagnostic laparoscopy;
Exclusion Criteria:
1. Histological histological diagnosis of squamous cell carcinoma (adenosquamous
carcinoma mainly including squamous cell carcinoma), carcinoid, undifferentiated
carcinoma or other unclassified carcinoma;
2. Patients with HER2-positive status are excluded;
3. Patients with distant metastases other than primary gastric cancer (any M1 stage);
4. Patients with contraindications (laparoscopic surgery, open surgery, neoadjuvant
chemotherapy);
5. Patients who can not undergo radical surgical resection (D2 radical resection);
6. Previous antitumor therapy (including chemotherapy, radiotherapy, molecular targeted
therapy and hormone therapy);
7. Previously received immunological drugs such as PD-1/PD-L1, CTLA-4 or other
immunological or molecular targeted therapies;
8. When virological testing prior to screening showed any of the following:
1. patients with active hepatitis (HBV DNA≥1*103 copies or ≥200IU/mL);
2. Anti - HCV positive;
3. HIV positive;
9. Patients or their families refused to sign this informed consent form to participate
in the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Xijing Hospital of Digestive Diseases
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Recruiting
Start date:
July 18, 2022
Completion date:
July 18, 2026
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05507658
