Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma Clinical Trial
Official title:
A Randomized, Open-label, Controlled, Multicenter Phase III Study of Hydrochloride Capsule Combined With AK105 Injection Versus Standard Second-line Chemotherapy for Advanced Gastric and Gastro-oesophageal Junction Adenocarcinoma
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.
| Status | Not yet recruiting |
| Enrollment | 528 |
| Est. completion date | December 31, 2023 |
| Est. primary completion date | October 31, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 75 Years |
| Eligibility |
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 > 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. |
| Country | Name | City | State |
|---|---|---|---|
| China | AnYang Tumor Hospital | Anyang | Henan |
| China | Beijing Luhe Hospital Capital Medical University | Beijing | Beijing |
| China | Beijing Shijitan Hospital Affiliated to Capital Medical University | Beijing | Beijing |
| China | Beijing Tsinghua Changgung Hospital | Beijing | Beijing |
| China | Peking University Shougang Hospital | Beijing | Beijing |
| China | The Sixth Medical Center of PLA General Hospital | Beijing | Beijing |
| China | Hunan Cancer Hospital | Changsha | Hunan |
| China | The Second Xiangya Hospital of Central South University | Changsha | Hunan |
| China | Xiangya Hospital Central South University | Changsha | Hunan |
| China | Fujian Provincial Cancer Hospital | Fuzhou | Fujian |
| China | Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong |
| China | The Sixth Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
| China | Harbin Medical University Cancer Hospital | Harbin | Heilongjiang |
| China | The First Affiliated Hospital of Anhui Medical University | Hefei | Anhui |
| China | Shandong Cancer Hospital | Jinan | Shandong |
| China | The First People's Hospital of kashi region | Kashi | XinJiang Uighur Autonomous Region |
| China | The First Hospital of Lanzhou University | Lanzhou | Gansu |
| China | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi |
| China | Jiangsu Cancer Hospital | Nanjing | Jiangsu |
| China | Jiangsu Province Hospital | Nanjing | Jiangsu |
| China | Guangxi Medical University Affiliated Tumor Hospital | Nanning | Guangxi Zhuang Autonomous Region |
| China | Nantong Cancer Hospital | Nantong | Jiangsu |
| China | Quanzhou First Hospital | Quanzhou | Fujian |
| China | The Second Affiliated Hospital of Fujian Medical University | Quanzhou | Fujian |
| China | Shanghai General Hospital | Shanghai | Shanghai |
| China | Liaoning Cancar Hospital | Shenyang | Liaoning |
| China | The Fourth Hospital of Hebei Medical University | Shijiazhuang | Hebei |
| China | Shanxi Provincial Cancer Hospital | Taiyuan | Shanxi |
| China | Tianjin Medical University Cancer Institute and Hospital | Tianjing | Tianjing |
| China | Tianjin Medical University General Hospital | Tianjing | Tianjing |
| China | Hubei Cancer Hospital | Wuhan | Hubei |
| China | Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Wuhan | Hubei |
| China | Union Hospital,Tongji Medical College,Huazhong University of Science and Technology | Wuhan | Hubei |
| China | Gansu Wuwei Tumour Hospital | Wuwei | Gansu |
| China | Hospital of Jiangnan University | Wuxi | Jiangsu |
| China | Wuxi People's Hospital | Wuxi | Jiangsu |
| China | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shanxi |
| China | The Second Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shanxi |
| China | The First Affiliated Hospital of Xiamen University | Xiamen | Fujian |
| China | Zhongshan Hospital Xiamen University | Xiamen | Fujian |
| China | Xinxiang Central Hospital | Xinxiang | Henan |
| China | People's Hospital of Ningxia Hui Autonomous Region | Yinchuan | Ningxia Hui Autonomous Region |
| China | Affiliated Hospital of Guangdong Medical University | Zhanjiang | Guangdong |
| China | Henan Cancer Hospital | Zhengzhou | Henan |
| China | The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
| Lead Sponsor | Collaborator |
|---|---|
| Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Overall survival (OS) | OS defined as the time from randomization to death from any cause. Subjects who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive. | up to 45 weeks | |
| Secondary | Progression-free survival (PFS) | PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause. | up to 45 weeks | |
| Secondary | Overall response rate (ORR) | Percentage of subjects achieving complete response (CR) and partial response (PR). | up to 45 weeks | |
| Secondary | Disease control rate (DCR) | Percentage of subjects achieving complete response (CR) and partial response (PR) and stable disease (SD). | up to 45 weeks | |
| Secondary | Duration of response (DOR) | DOR defined as time from earliest date of disease response to earliest date of disease progression based on radiographic assessment. | up to 45 weeks |