Tislelizumab Combined With XELOX as Perioperative Therapy for Locally Advanced Gastric Cancer
Study Details
Study Description
Brief Summary
The effective treatment of locally advanced gastric cancer has always been a research hotspot in academia. In recent years, mainstream studies have shown that the treatment mode of locally advanced gastric cancer 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 LAGC, the perioperative 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 locally advanced gastric cancer with clinical stage of cT3-4a N+ M0. 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 perioperative management of resectable LAGC patients, and further explore the safety and therapeutic effect of chemotherapy together with tirelizumab in the perioperative period of LAGC, eventually, providing a new option for the perioperative treatment of LAGC.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tislelizumab combined with XELOX Tirelizumab 200mg, iv.gtt, D1, Q3W; Chemotherapy: Oxaliplatin (130 mg/m2), iv.gtt, D1, Q3W; Capecitabine (1000mg/m2), P.O.B.I.D., D1-D14, Q3W. |
Drug: Tislelizumab combined with Oxaliplatin and Capecitabine
Drugs:
Tirelizumab 200mg, iv.gtt, D1, Q3W;
Chemotherapy (XELOX) : oxaliplatin (130 mg/m2), iv.gtt, D1, Q3W; Capecitabine (1000mg/m2), P.O.B.I.D., D1-D14, Q3W.
Neoadjuvant therapy:
Tislelizumab combined with XELOX for 3 weeks;
D2 radical gastrectomy within 3-6 weeks after neoadjuvant therapy, with more than 15 lymph nodes dissected.
Adjuvant therapy:
From 4 to 8 weeks after surgery, the treatment dose was the same as above;
Patients who achieved pCR and non-PCR on pathological evaluation were treated with tirelizumab +XELOX 6-8 cycles;
Tumor evaluation performed every 3 cycles;
The maximum duration of adjuvant therapy was not more than 8 cycles.
|
Outcome Measures
Primary Outcome Measures
- Major pathological response rate(MPR) [From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 years]
Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time.
Secondary Outcome Measures
- Pathological complete response rate(pCR) [From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.]
- R0 resection rate [From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.]
Rate of microscopically margin-negative resection
- TRAEs and postoperative complications [Investigator assessment,from the initiation date of the operation day, assessed up to 1 years.]
Including TRAEs and postoperative complications Complications refer to the occurrence of another or several diseases related to the therapeutic behavior of this disease during the treatment of a certain disease.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Voluntarily sign the informed consent;
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Aged 18-80 (including 18 and 80), both sexes;
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Karnofsky score ≥70, ECOG score ≤1;
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Clinical stage Ⅲ locally advanced gastric cancer (cT3-4a N+ M0, stage cIII) confirmed by basic ultrasound gastroscopy, enhanced CT/MRI or diagnostic laparoscopy;
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Biopsy histologically confirmed adenocarcinoma (including Lauren grade);
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Radiographic evidence during the screening period showed at least one measurable and/or evaluable lesion according to RECIST1.1 criteria;
Exclusion Criteria:
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Histological histological diagnosis of squamous cell carcinoma (adenosquamous carcinoma mainly including squamous cell carcinoma), carcinoid, undifferentiated carcinoma or other unclassified gastroesophageal junction carcinoma;
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Patients with known HER2-positive status (patients with unknown HER2 status must be confirmed at the local hospital) are excluded;
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Patients with distant metastases other than primary gastric cancer (any M1 stage);
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Patients with contraindications (laparoscopic surgery, open surgery, neoadjuvant chemotherapy);
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Patients who can not undergo radical surgical resection (D2 radical resection);
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Previous antitumor therapy (including chemotherapy, radiotherapy, molecular targeted therapy and hormone therapy);
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Previously received immunological drugs such as PD-1/PD-L1, CTLA-4 or other immunological or molecular targeted therapies;
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When virological testing prior to screening showed any of the following:
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patients with active hepatitis (HBV DNA≥1*103 copies or ≥200IU/mL);
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Anti - HCV positive;
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HIV positive;
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Patients or their families refused to sign this informed consent form to participate in the study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Xijing Hospital of Digestive Diseases | Xi'an | Shaanxi | China | 710000 |
Sponsors and Collaborators
- Xijing Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Gang Ji -1