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Tegafur Gimeracil Oteracil Potassium Capsule

Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule; T25mg,G7.25mg,O24.5mg\*42 capsules/box), manufactured by Jiangsu Hengrui Medicine Co., Ltd.,

Peng Yuan, MD

Dan Yu, MD

Hong Dai, MD

Donggui Wan, MD

Lijun Di, MD

Huihui Rao, MD

Junlan Yang, MD

Long Wang, MD

Wei Liu, MD

Zhongsheng Tong, MD

Binghe Xu, MD, PhD

The purpose of this study is to assess the effectiveness and safety profile of Aiyi®(Tegafur Gimeracil Oteracil Potassium Capsule, TS-1) as a second line therapy in Chinese female patients with advanced metastatic breast cancer.

Tegafur Gimeracil Oteracil Potassium Capsule is a novel oral derivative of the 5-fluorouracil(5-FU) prodrug tegafur combined with two modulators. Recent clinical trial has reported the promising effect of Tegafur Gimeracil Oteracil Potassium Capsule in metastatic breast cancer. The innovative drug, S-1, has obtained the approval of treatment of advanced breast cancer in Japan, meanwhile, Generic drug is only approved for the indication of gastric cancer in China mainland by Chinese authority, SFDA, and no Chinese clinical study data of TS-1 in breast cancer so far.

Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer

An Open-label, Single-arm, Multicenter, Phase II Study to Assess the Efficacy and Safety of Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule) as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer

Peking University Cancer Hospital & Institute

Beijing Chao Yang Hospital

Chinese PLA General Hospital

China-Japan Friendship Hospital

Tianjin Medical University Cancer Institute and Hospital

Hebei Tumor Hospital

Chinese Academy of Medical Sciences

Deputy Director of Department of Medical Oncology

Digestive System Diseases

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Oxaliplatin

Participants receive camrelizumab 200 mg intravenously (IV) on the first day (q3w), then oxaliplatin 130 mg/m\^2, IV on the first day (q3w), and tegafur gimeracil oteracil potassium capsule 80 mg/m\^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Three weeks as a course of treatment, a total of 8 courses.

Camrelizumab, 200 mg IV for 30-60 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.

Camrelizumab

Oxaliplatin: 130 mg/m\^2 IV for 2-6 hour in first day which will be administered at least 30 min after completion of camrelizumab administration, every 3 weeks. Repeated every 21 days, 21 days for a cycle.

Tegafur gimeracil oteracil potassium capsule: 80 mg/m\^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Repeated every 21 days. 21 days for a cycle.

Tegafur gimeracil oteracil potassium capsule

Jiren Yu

This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the safety of tegafur gimeracil oteracil potassium capsule plus oxaliplatin and Camrelizumab as adjuvant therapy in stage III gastric cancer, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), overall survival (OS) and treatment completion rate.

1. Study population: participants with stage III gastric cancer confirmed by postoperative pathology according to American Joint Committee on Cancer (AJCC) / Union for International Cancer Control (UICC) 8th Tumor Node Metastasis (TNM) staging classification.
2. Sample size: single arm design was used in this study and 52 participants were estimated to be enrolled.
3. Research content: In this study, within 4-6 weeks after the completion of the operation, the participants were selected and qualified for this study, and were scheduled to receive 200mg camrelizumab once intravenous infusion on the first day (q3w), then 130mg/m\^2 oxaliplatin on the first day (q3w), and tegafur gimeracil oteracil potassium capsule was taken as follow: surface area is less than 1.25, 80mg per day, twice a day; ≥1.25 \~ \<1.5, 100mg per day, twice a day; ≥1.5, 120mg per day, twice a day, and oral administration for 1-14 days every 3 weeks. Three weeks as a course of treatment, a total of 8 courses, after treatment, safety visit and survival follow-up will be carried out. A total of 3 years follow-up time is scheduled since the first medication, and the frequency is once every 3-6 months within 2 years, and once every 6-12 months for the third year.
4. Adverse events (AEs) management: To minimize the risk of AEs, the investigators will monitor carefully to determine whether or not they are within the expected range. The degree of AEs is evaluated according to The National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE v 4.0). Investigators will also conduct a thorough examination and adopt an appropriate system to take any necessary measures to deal with AEs.

Adjuvant Chemotherapy in Combination With Camrelizumab for Stage III Gastric Cancer (FOCUS-02)

A Multi-center, Phase II Study to Evaluate Safety and Efficacy of Adjuvant Chemotherapy With Tegafur Gimeracil Oteracil Potassium Capsule Plus Oxaliplatin and Camrelizumab for Stage III Gastric Cancer (FOCUS-02)

The incidences and types of adverse events that occur during treatment will be evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.

Percentage of participants who complete eight cycles of chemotherapy in combination with Camrelizumab.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer	NCT01492543	Breast Cancer	Tegafur Gimerac...	18 Years - 75 Years	ChineseAMS
Study of TS-1 as 2nd Line Treatment in Patients With Advanced Metastatic Breast Cancer	NCT01492543	Breast Cancer	Tegafur Gimerac...	18 Years - 75 Years	ChineseAMS
Adjuvant Chemotherapy in Combination With Camrelizumab for Stage III Gastric Cancer (FOCUS-02)	NCT04515615	Gastric Cancer ...	Camrelizumab Oxaliplatin Tegafur gimerac...	18 Years - 75 Years	First Affiliated Hospital of Zhejiang University

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