A Prospective Cohort Study on the Treatment of Locally Advanced Gastric Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSouthwest Hospital, China
About this trial
The clinical trial aims to assess the efficacy and safety of Tislelizumab combined with the SOX regimen and HIPEC in treating locally advanced gastric cancer. The primary and secondary objectives are as follows:
To evaluate the 3-year disease-free survival (DFS) in patients with locally advanced gastric cancer treated with systemic SOX chemotherapy plus Tislelizumab and HIPEC.
To assess the major pathological response (MPR) in these patients. Secondary objectives include safety, pathological complete response (pCR), progression-free survival (PFS), tumor regression grade (TRG), overall survival (OS), incidence of adverse reactions during treatment, postoperative adverse reactions, and treatment efficacy.
Participants will:
Be willing to receive SOX plus Tislelizumab combined with HIPEC treatment (exposure group), undergo HIPEC followed by SOX and Tislelizumab to achieve stable disease (SD), partial response (PR), or complete response (CR). Patients who can undergo surgery after the second exploration will receive surgery and HIPEC treatment. If surgery is not possible, a multidisciplinary team (MDT) discussion will follow to determine the next treatment plan. Patients with progressive disease (PD) will also have an MDT discussion to determine the subsequent treatment.
Be willing to receive SOX combined with HIPEC treatment (observation group), undergo HIPEC followed by SOX to achieve SD, PR, or CR. Patients who can undergo surgery after the second exploration will receive surgery and HIPEC treatment. If surgery is not possible, an MDT discussion will follow to determine the next treatment plan. Patients with PD will also have an MDT discussion to determine the subsequent treatment.
Treatment details:
SOX: S-1 dosage based on body surface area (BSA): \<1.25m², 40 mg bid orally, 1.25-1.5m², 50 mg bid orally, ≥1.5m², 60mg bid orally, days 1-14; Q3W; Oxaliplatin 130mg/m² IV day 1, for a total of 3 cycles.
Tislelizumab: 200mg IV, day 1, Q3W, for a total of 3 cycles. HIPEC: Docetaxel: 120mg, day 1, day 3.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with newly diagnosed Her-2 negative gastric adenocarcinoma, with no prior chemotherapy, radiotherapy, or other anti-cancer treatments before the start of the clinical trial.
Age between 18 to 80 years old, Eastern Cooperative Oncology Group (ECOG) performance status: 0-1.
Staging according to the American Joint Committee on Cancer (AJCC) 8th edition is T4aNxM0, without obstruction, perforation, or bleeding risk.
Good bone marrow reserve function, with the following blood criteria: white blood cell count ≥3×10^9/L, neutrophils ≥1.5×10^9/L, platelet count ≥100×10^9/L, hemoglobin ≥90 g/L.
Disqualifiers
Participants who have been enrolled in any other drug clinical trial or have participated in any drug clinical trial within the last month.
Any anti-cancer treatments (chemotherapy, radiotherapy, surgery, immunotherapy, biotherapy, chemoembolization) other than the study medication (palliative external beam radiation for non-target lesions is allowed).
Prior use of similar chemotherapy drugs or immune checkpoint inhibitors.
Presence of metastatic lesions in the liver, lungs, para-aortic lymph nodes, bones, brain, adrenal glands, or pelvic and abdominal cavity.
Trial population
Patients with newly diagnosed Her-2 negative gastric adenocarcinoma，Staging according to the American Joint Committee on Cancer (AJCC) 8th edition is T4aNxM0, without obstruction, perforation, or bleeding risk
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Tislelizumab
DrugTislelizumab: 200mg IV, day 1, Q3W, for a total of 3 cycles.
SOX
DrugSOX: S-1 dosage based on body surface area (BSA): \<1.25m², 40 mg bid orally, 1.25-1.5m², 50 mg bid orally, ≥1.5m², 60mg bid orally, days 1-14; Q3W; Oxaliplatin 130mg/m² IV day 1, for a total of 3 cycles.
HIPEC
DeviceHIPEC: Docetaxel: 120mg, day 1, day 3.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
3-year disease-free survival
The 3-year disease-free survival (DFS) in patients with locally advanced gastric cancer treated with systemic SOX chemotherapy plus Tislelizumab combined with HIPEC
Time frame
3 yearsSecondary outcomes
1
MPR
Systemic SOX chemotherapy combined with Tislelizumab and HIPEC for locally advanced gastric cancer patients' major pathological response (MPR).
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov