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Spots Global Cancer Trial Database for A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers

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Trial Identification

Brief Title: A Study to Evaluate the Efficacy and Safety of Toripalimab Injection in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers

Official Title: A Single-arm, Multicenter, Phase II Clinical Study to Evaluate the Efficacy and Safety of Toripalimab Injection (JS001) in the Treatment of Recurrent or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma Who Have Failed at Least Two Prior Lines of Therapy and Are Positive Specific Markers

Study ID: NCT04603040

Interventions

Toripalimab

Study Description

Brief Summary: This is a single-arm, multicenter, phase 2 study to assess the efficacy and safety of Toripalimab Injection (JS001) in patients with advanced recurrent or metastatic gastric or gastroesophageal junction adenocarcinoma who have failed at least 2 prior lines of therapy and are positive for specific markers. Patients who meet the requirements will be treated with Toripalimab injection 240 mg once every 3 weeks (q3w) until disease progression based on imaging according to RECIST 1.1 criteria judged by the investigator, or intolerable toxicity, or withdrawal of informed consent, or withdrawal of treatment judged by the investigator, or voluntarydiscontinuation of treatment by the patient with CR of more than 6 months, or up to 2 years of treatment for JS001, whichever occurs first. For the case that the patient shows disease progression on imaging according to RECIST 1.1, as long as the investigator judges that the patient can still benefit from continued medication, the treatment with Toripalimab Injection can be continued until the progression on imaging assessed by the investigator for the second time. The clinical benefit is based on the results of comprehensive assessment by the investigator in combination with imaging findings and clinical condition when the patient has no intolerable toxicity or the symptoms worsen due to disease progression. Tumor assessments are performed at screening (as the baseline), every 6 weeks from the first dose in the first year, and every 9 weeks from the second year until radiologically documented progressive disease (PD), or second disease progression judged by the investigator (for patients with disease progression shown by first imaging, but who can continue treatment judged by the investigator), or withdrawal of informed consent by the patient, or loss to follow-up, or start of a new anti-tumor therapy, or the termination of the study. If a patient withdraws from the study for reasons other than disease progression (including due to the AE or because the treatment interval is beyond the window) and no disease progression occurs at the time of withdrawal, radiographic assessments should be continued until disease progression, death, or start of a new anti-tumor therapy. Patient medication management is based on the investigator's tumor assessment.

Detailed Description:

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China

Affiliated Hospital of Hebei University, Baoding, , China

Peking University International Hospital, Beijing, , China

The First Hospital of Jilin University, Ch'ang-ch'un, , China

Sichuan Cancer Hospital, Chengdu, , China

Fujian Provincial Cancer Hospital, Fuzhou, , China

Union Hospital affiliated to Fujian Medical University, Fuzhou, , China

Affiliated Tumor Hospital of Guangzhou Medical University, Guangzhou, , China

Guangdong Provincial People's Hospital, Guangzhou, , China

The First Affiliated Hospital of Sun Yat-sen University, Guangzhou, , China

The sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou, , China

The First Affiliated Hospital of Zhejiang University Medical College, Hangzhou, , China

Zhejiang Cancer Hospital, Hangzhou, , China

Zhejiang University School of Medicine, Sir Run Run Shaw Hospital, Hangzhou, , China

Affiliated Tumor Hospital of Harbin Medical University, Harbin, , China

Anhui Provincial Hospital, Hefei, , China

Second Affiliated Hospital of Anhui Medical University, Hefei, , China

The First Affiliated Hospital of Anhui Medical University, Hefei, , China

The First Affiliated Hospital of Bengbu Medical College, Hefei, , China

Henan Cancer Hospital, Henan, , China

The First Affiliated Hospital of Nanhua University, Hengyang, , China

Shandong Cancer Hospital, Jinan, , China

The first Affiliated Hospital of Henan University of Science and Technology, Luoyang, , China

Jiangxi Provincial Cancer Hospital, Nanchang, , China

The First Affiliated Hospital of Nanchang University Junhe Li, Nanchang, , China

Jiangsu Cancer Hospital, Nanjing, , China

The First Affiliated Hospital of Guangxi Medical University, Nanning, , China

Nantong Tumor Hospital, Nantong, , China

Affiliated Hospital of Qingdao University, Qingdao, , China

Shengjing Hospital of China Medical University, Shenyang, , China

The First Affiliated Hospital of Soochow University, Suzhou, , China

The Second Affiliated Hospital of Soochow University, Suzhou, , China

Shanxi Cancer Hospital, Taiyuan, , China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology, Wuhan, , China

The First Affiliated Hospital of Xiamen University, Xiamen, , China

The First Affiliated Hospital of Xinjiang Medical University, Xinjiang, , China

Xuzhou Central Hospital, Xuzhou, , China

First Affiliated Hospital of Zhengzhou University, Zhengzhou, , China

Zhengzhou Central Hospital, Zhengzhou, , China

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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