Malignant solid tumors
Conditions
Interventions
Advanced solid tumor group with slow progression after treatment with PD-1 inhibitor regimen:Norcantharidin treatment
Controls with locally advanced/metastatic microsatellite-stable colorectal cancer who initially received PD-1 inhibitor regimen:Treatment with PD-1 inhibitors
Locally advanced/metastatic microsatellite-stable colorectal cancer initially treated with a PD-1 inhibitor regimen group:Norcantharidin treatment
Sponsors
Shanghai Tongren Hospital
Eligibility
Sex/Gender
All
Age
12 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.The main inclusion criteria for cohort 1 were: (1) Age >=18 years old (>=12 years old for bone and soft tissue sarcoma subjects), regardless of gender; (2) Pathologically proven advanced/metastatic malignant solid tumors; (3) There is at least one evaluable lesion; (4) Imaging examination after treatment with PD-1 inhibitor indicated tumor enlargement but did not meet the PD standard in RECIST 1.1, that is, the sum of the longest tumor diameter increased but did not reach 20%; (5)ECOG physical status score 0-2; (6) Expected survival of at least 3 months; (7) Adequate organ and bone marrow function, no serious hematopoietic function and heart, lung, liver, kidney function abnormalities; (8) Volunteer to participate in this study. 2.Based on the preclinical colorectal cancer research data by Professor Zhuang Zhengping, Cohort 2 aims to enroll colorectal cancer patients. The primary inclusion criteria are as follows: (1) Age >=18 years old, regardless of gender; (2) Locally advanced/metastatic colorectal cancer confirmed by pathology, microsatellite stability confirmed by immunohistochemistry or genetic testing; (3) At least one evaluable lesion according to RECIST standard 1.1; (4) Progression or intolerance following at least previous first-line treatment for locally advanced/metastatic disease; (5) had not received PD-1, PDL-1, CTLA-4 inhibitors and other immunotherapy; (6)ECOG physical status score 0-2; (7) Expected survival of at least 3 months; (8) Adequate organ and bone marrow function, no serious hematopoietic function and heart, lung, liver, kidney function abnormalities; (9) Volunteer to participate in this study.
Exclusion criteria
Exclusion criteria: (1)Received treatments potentially having immunosensitizing effects, such as radiotherapy, TACE, or tumor ablation therapy, within the past 8 weeks; (2) Uncontrolled central nervous system metastasis; (3) Pregnant or breastfeeding women; (4) Men or women unwilling to use appropriate contraceptive measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3-month progression-Free Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective remission rate, ORR;Disease control rate, DCR;Duration of remission,DoR;Overall survival, OS;Adverse events, AE;Serious adverse events, SAE;Expression of PD-L1 in tumor tissue;Microsatellite stable state, MSS;Tumor mutation burden, TMB; | — |
Countries
China
Contacts
Public ContactJianjun Zhang
Shanghai Tongren Hospital
Outcome results
None listed