The role of low-dose radiotherapy in maintenance therapy after first-line treatment of HER2-negative advanced gastric cancer
Phase 2
- Conditions
- Her2-negative advanced gastric cancer
- Registration Number
- ChiCTR2400089076
- Lead Sponsor
- Sichuan Mianyang 404 Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- All subjects should sign the informed consent form before starting the study and be able to comply with the program visit and related procedures. <br>2. Age =18. <br>3. The cytological or histological diagnosis of gastric cancer is unresectable and locally advanced or metastatic gastric cancer or cancer of the gastroesophageal junction, patients with SD and PR assessed after 4-6 cycles of first-line therapy with Oxaliplatin plus capecitabine plus PD-1 inhibitors. <br>4. Agree to provide tumor tissue samples, either previously archived or freshly obtained, for biomarker testing. <br>5. The expression of Her-2 was negative by immunohistochemistry or FISH. <br>6. At least one measurable lesion (RECIST v1.1 criteria) without prior radiotherapy. <br>7. The lesions were =5 cm in diameter. <br>8. ECOG scores range from 0 to 1. Life expectancy > 3 months. <br>10. Vital organs and bone marrow function meet the requirements. <br>11. Thyroid function was normal. <br>12.Toxic side effects (except alopecia, etc.) of previous treatment were =1 grade or returned to baseline. <br>13.The investigators had good judgment compliance and were able to complete prescribed visits, treatments and laboratory examinations according to the study protocol. <br>14. For women of reproductive age, pregnancy was excluded.
Exclusion Criteria
- Participants with active central nervous system (CNS) metastases (including but not limited to carcinomatous meningitis and spinal cord compression) were excluded. <br>2. With tumor emergency, need immediate treatment. <br>3. Subjects with peripheral neuropathy. <br>4.The investigators considered significant coagulation abnormalities or were receiving thrombolytic or anticoagulant therapy. <br>5. Subjects required systemic treatment with corticosteroid (10 mg of prednisone daily) or other immunomodulatory agents (interleukin-2, interferon-alpha, interferon-gamma, cyclosporine, G-CSF, mTOR inhibitor) for 28 days prior to study treatment. <br>6. Heart disease or impairment of cardiac function of clinical significance. <br>7.Third space effusions with clinical symptoms, such as pericardial effusions, pleural effusions, and abdominal effusions, which can not be controlled by drainage or other treatment.<br>8. Known allergies to drugs or excipients, known to cause severe allergic reactions to any of the mabs;.<br>9. Severe infection occurred within 4 weeks before the start of study treatment. <br>10.Active autoimmune disease (congenital or acquired) is known or suspected. <br>11.Organ Transplantation (other than keratoplasty) or Hematopoietic stem cell transplantation is known. <br>12.Have other serious diseases that are out of control. <br>13.A pregnant or lactating woman. <br>14.Other malignant tumors occurred within 5 years before the first dose. <br>15.Known mental illness, alcoholism, drug use or substance abuse. <br>16.Subjects who had received or planned to receive the live vaccine within 4 weeks before the first study drug were enrolled.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method PFS;
- Secondary Outcome Measures
Name Time Method Objective response rate;Disease control rate;Duration of relief;Overall survival;