Spots Global Cancer Trial Database for KN035 in Patients With Advanced Multiple Primary Tumors

Study Description

Brief Summary: This study is a prospective, single arm, single center exploratory clinical research, to evaluate KN035 late treatment in patients with Multiple Primary tumors (MPC, Multiple Primary working) clinical benefit.In the study, all subjects meeting the criteria for inclusion will be enrolled in the KN035 treatment group, and patients cannot receive any other anti-tumor treatment during the study period.The primary endpoint of the study was defined as patients who could be assessed by imaging, and the optimal Objective Response Rate (ORR) based on RECIST 1.1 standard, while the secondary endpoint was safety (nci-ctcae 4.0), DCR (Disease Control Rate), DoR (Duration of Response), progression-free survival (PFS),1) Overall Survival and Overall Survival;The end point of the exploratory study was the correlation between different molecular types and the efficacy of immunotherapy.

Detailed Description: Patients diagnosed with advanced MPC in the study should be enrolled as: Histopathological diagnosis of multiple primary tumors, and is currently suffering from advanced colorectal cancer;Except for bowel cancer, no anti-tumor treatment is needed for other tumors during screening. The maximum time interval between screening and treatment was 2 weeks (±7 days).Efficacy and safety were evaluated at 4 weeks (±7 days), 8 weeks (±7 days) after treatment, and every 8 weeks (±7 days) thereafter.Once a subject develops disease progression (based on investigator evaluation or imaging evidence), the subject should discontinue the study.Cessation of treatment for any reason should be followed by a study end visit within 4 weeks (±7) days after the last study administration to collect information on all possible adverse events and drug combinations.Drug - related or possibly related adverse events should be followed up until they are stable or resolved.SAE should be documented within 30 days of study cessation.KN035 can be used for up to 2 years. When desease progression is suspected, researchers are allowed to reconfirm disease progression after 4 weeks using irRECIST criteria.During the confirmation of disease progression, if the investigator decides that the subject should continue to receive KN035 treatment, the following criteria must be met: The researchers assessed whether the subjects had benefited or were likely to continue to benefit: ①Subjects can tolerate study drug therapy; ②There were no medical events (e.g., central nervous system metastases) in which tumor progression was rapid or urgent intervention was required. Study endpoint analysis will be performed when the last patient is followed for 24 weeks or disease progression or death is observed.If there is still no disease progression or intolerable adverse reactions, the patient will continue to receive KN035 treatment until the disease progression, death, occurrence of intolerable adverse reactions or treatment for 1 year (the researcher will give follow-up treatment recommendations according to the specific situation, if the original treatment is continued, the patient can still receive KN035 treatment for free).Treatment options after disease progression will be implemented at the discretion of the investigator.After the end of the study visit, subjects will enter the post-study follow-up period to collect survival data OS.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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