Neoadjuvant Chemo-hypoRT Plus PD-1 Antibody (Tislelizumab) in Resectable LA-G/GEJ (NCT05941481) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Neoadjuvant Chemo-hypoRT Plus PD-1 Antibody (Tislelizumab) in Resectable LA-G/GEJ
China21 participantsStarted 2023-06-10
Plain-language summary
Gastric cancer is the third leading cause of death due to cancer worldwide. Although the consensus on the surgical treatment has resulted in the improvement of curative effect during the past decades, controversies remained for the perioperative therapy of gastric cancer, especially in the selection of the optimal neoadjuvant regimens. Immunotherapy with anti-programmed cell death-1 (PD-1) antibody has demonstrated moderate efficacy in selected patients with advanced gastric adenocarcinoma. Hypofractionated radiotherapy (HypoRT) may act synergistically with immunotherapy to enhance antitumor responses. This phase II trial study want to exploit the efficacy and safety to give PD-1 antibody (Tislelizumab) with combination chemotherapy and HypoRT before surgery in treating adult patients with gastric or gastroesophageal junction adenocarcinoma.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Histologically or cytologically confirmed adenocarcinoma involving the gastroesophageal junction or gastric cardia.
✓. Having an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 within 7 days before enrollment.
✓. Being histologically diagnosed with adenocarcinoma.
✓. Having tumor lesions at stomach or gastroesophageal junction (Siewert type II or III);
✓. Clinically diagnosed stage T1-2N+M0/T3-T4aNanyM0 according to ultrasound endoscopy or enhanced CT/MRI scan.
✓. At least one evaluable lesion in abdominal CT/MRI according to RESIST 1.1 is required.
✓. Surgical consultation at enrolling site to confirm that patient will be able to undergo curative resection after completion of neoadjuvant therapy =\< 56 days prior to registration.
✓. Physical condition and adequate organ function to ensure the success of abdominal surgery.
Exclusion criteria
What they're measuring
1
pathological complete remission (pCR) rate
Timeframe: From date of treatment allocation and during treatment period up to 1 year
. Patients with distant metastasis or unresectable primary lesion.
✕. Received prior treatment or receiving current treatment for this malignancy.
✕. Patients who have digestive tract bleeding in 2 weeks before recruitment or with high risk of bleeding.
✕. Perforation / fistula of GI tract in 6 months before recruitment.
✕. Patients with upper GI tract obstruction or functional abnormality or malabsorption syndrome, which can affect absorption of apecitabine.
✕. Patients with active autoimmune disease or history of refractory autoimmune disease.
✕. Patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured locally tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ.
✕. Uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment.