a study of anlotinib hydrochloride capsule combined with ak105 injection in subject with advanced gastric and gastro-oesophageal junction adenocarcinoma

Conditions: Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma

Summary: this is a randomized, controlled, open-label, multicenter study to evaluate efficacy of ak105 injection combined with anlotinib hydrochloride capsules versus standard second-line chemotherapy. patients are treated with ak105 injection combined with anlotinib hydrochloride capsules or standard second-line chemotherapy, with 1:1 random ratio.


Eligibility criteria:
inclusion criteria: * 1. understood and signed an informed consent form; 2.eastern cooperative oncology group (ecog) performance status score of 0 or 1; life expectancy ≥ 3 months; 3. histopathology or cytology confirmed as metastatic or local advanced gastric and gastro-oesophageal junction adenocarcinoma; 4. first-line standard chemotherapy regimen in patients with advanced gastric or gastroesophageal junction adenocarcinoma after treatment failure; 5. has at least one measurable lesion; 6. weight ≥40 kg or bmi ≥18.5; 7. adequate organ function; 8. male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ;no pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization. exclusion criteria: * 1. histopathology confirmed as squamous cell carcinoma, carcinoid, undifferentiated carcinoma, or other gastric cancer; 2. her2 positive; 3. has received paclitaxel or docetaxel in the first-line treatment; 4. has received paclitaxel or docetaxel in the neoadjuvant or adjuvant treatment regimen and have relapsed or metastasized within 6 months after the last dose; 5. has other malignant tumors within 5 years; 6. has used anti-angiogenic drugs such as anlotinib, apatinib, lenvatinib, sorafenib, sunitinib, bevacizumab, or related immunotherapy drugs for pd-1, pd-l1, etc; 7. severe hypersensitivity after administration of other monoclonal antibodies; 8. has spinal cord compression, cancerous meningitis and symptomatic brain metastasis； 9. has adverse events caused by previous therapy except alopecia that did not recover to ≤grade 1; 10. has received radiotherapy, chemotherapy and surgery within 4 weeks before the first dose; 11. has gastrointestinal bleeding tendency within 4 weeks before the first dose; 12. the tumor has invaded important blood vessels and will cause fatal bleeding; 13. has multiple factors affecting oral medication; 14. has uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 15. has any active autoimmune disease or history of autoimmune disease; 16. immunosuppressant or systemic or absorbable local hormone therapy is required to achieve the aim of immunosuppression (dose \&gt; 10mg/ day prednisone or other therapeutic hormones) and is still used within 2 weeks after the first administration; 17. has any serious and / or uncontrolled disease; 18. has active viral infection; 19. has participated in other anticancer drug clinical trials within 4 weeks; 20. according to the judgement of the investigators, there are other factors that may lead to the termination of the study.