相关临床试验
158
4 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
已完成
102
64.6%
尚未招募
4
2.5%
招募中
48
30.4%
暂停
1
0.6%
暂无批准数据
- The Japanese JCOG0603 phase II/III trial found that adjuvant mFOLFOX6 after hepatectomy for colorectal liver-only metastases improved disease-free survival but failed to provide overall survival benefit after 7.7 years median follow-up. - Despite a 28% relative reduction in recurrence risk with adjuvant chemotherapy, five-year overall survival rates were similar between treatment groups at 73.4% versus 80.1% for surgery alone. - The findings challenge routine use of postoperative mFOLFOX6 in resectable colorectal liver metastases, highlighting the need for biomarker-driven patient selection strategies. - Post-recurrence management differences, including higher rates of repeat surgical resection in the surgery-alone arm, may have contributed to convergent overall survival outcomes between treatment groups.
- Chugai Pharmaceutical obtained regulatory approval from Japan's Ministry of Health, Labour and Welfare for Tecentriq (atezolizumab) to treat relapsed or refractory extranodal natural killer/T-cell lymphoma, nasal type (ENKL). - Tecentriq becomes the first immune checkpoint inhibitor approved in Japan for ENKL, a rare malignant lymphoma where approximately 60% of patients relapse after initial treatment with no established standard therapy after relapse. - The approval was based on results from the phase II ATTACK study conducted by Japanese investigators, including National Cancer Center Hospital, evaluating efficacy and safety in relapsed/refractory ENKL patients. - Chugai also received approval for a 4-weekly dosing regimen for existing lung cancer and breast cancer indications, providing more flexible treatment planning and reducing hospital visit burden.
- Eisai Co., Ltd. received orphan drug designation from Japan's Ministry of Health, Labour and Welfare for tazemetostat hydrobromide (Tazverik®) to treat unresectable INI1-negative epithelioid sarcoma that has progressed after chemotherapy. - Epithelioid sarcoma is an extremely rare soft tissue cancer accounting for only 1% of all soft tissue sarcomas, with just 174 cases registered across major Japanese hospitals over a 10-year period from 2006 to 2015. - The EZH2 inhibitor targets a key molecular pathway in epithelioid sarcoma, where loss of INI1 protein occurs in over 90% of cases, leading to EZH2 activation that drives tumor onset and malignant progression. - A Phase II investigator-initiated trial (TAZETTA trial) led by the National Cancer Center Hospital is currently underway to evaluate tazemetostat's efficacy in this indication.
- Flatiron Health's international oncology research network has tripled in size over the past year, now encompassing more than 30 partnerships across the UK, Germany, and Japan. - The expansion brings Flatiron's total patient database above 5 million records, with new partnerships including major academic medical centers and national cancer centers in each country. - The company established Flatiron FORUM, a global consortium addressing data transportability challenges to support multinational cancer research and regulatory decisions. - Seven research studies using multinational real-world data have been completed within the past two years, demonstrating the platform's capability for cross-country cohort analyses.
- Japan is advancing decentralized clinical trials (DCTs) in oncology to address geographic barriers and improve access for patients with rare cancers or low-frequency genetic mutations. - Recent regulatory developments include 2023 guidelines for electronic informed consent and 2024 guidance on using remotely collected data, gradually establishing a legal framework for DCT adoption. - Three emerging DCT models in Japan include physician-led fully-remote trials, sponsor-led hybrid approaches, and remote pre-screening systems, all aimed at reducing patient travel burden while maintaining data integrity.
- Updated safety data from the ALINA trial reinforce adjuvant alectinib's role as a standard treatment for ALK-positive non-small cell lung cancer (NSCLC). - Alectinib demonstrated a manageable safety profile, with most adverse events being laboratory abnormalities and infrequently leading to treatment discontinuation. - The ALINA trial's DFS hazard ratio of 0.24 and CNS DFS hazard ratio of 0.22 highlight alectinib's significant efficacy in the adjuvant setting. - Alectinib, approved by the FDA in April 2024, is now a preferred adjuvant treatment option for patients with resected ALK-positive NSCLC.
