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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
pathological complete remission (pCR) rate
Timeframe: From date of treatment allocation and during treatment period up to 1 year
. Physical condition and adequate organ function to ensure the success of abdominal surgery.
Exclusion criteria
. 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.