Status and phase
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Treatments
About
This study evaluates the safety, tolerability, preliminary efficacy and pharmacokinetics of Simmitecan in patients with advanced solid tumors and Simmitecan, 5-fluorouracil and Leucovorin Calcium,thalidomide in patients with advanced solid tumor or advanced/metastatic colorectal cancer.
Enrollment
Sex
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Volunteers
Inclusion and exclusion criteria
Inclusion criteria
Patients who have fully understood the study, and are willing to sign the informed consent (ICF);
Patients with advanced solid tumor confirmed by histopathology and/or cytology were enrolled in Parts 1 and 2 of the study; Four groups of patients with advanced solid tumor confirmed by histopathology and/or cytology were enrolled in Part 3 of the study: Group 1 consisted of patients with rectal carcinoma, Group 2 consisted of patients with gastric carcinoma and esophageal carcinoma, Group 3 consisted of patients with biliary duct carcinoma and pancreatic carcinoma, and Group 4 consisted of patients with gastro-entero-pancreatic neuroendocrine carcinoma. Patients with advanced or metastatic CRC confirmed by histopathology and/or cytology were enrolled in Part 4 of the study; In Part 5 of the study, patients with advanced gastrointestinal tumor (including biliary tumor [gallbladder carcinoma, intra- or extra-hepatic biliary carcinoma], pancreatic carcinoma, hepatocellular carcinoma, esophageal carcinoma, gastric carcinoma, colorectal carcinoma, gastrointestinal stromal carcinoma, and gastro-entero-pancreatic neuroendocrine carcinoma) confirmed by histopathology were enrolled; In Part 6 of the study, patients with advanced gastrointestinal tumor (tentatively determined as biliary tumor, hepatocellular carcinoma, pancreatic carcinoma, and colorectal carcinoma); At least 5 unstained slices of tumor tissues must be obtained at baseline from patients participating in Parts 5 and 6 of the study: Primary lesion samples at the initial diagnosis or archived recently were acceptable. They were used to detect protein expression level of SOD1 and other related molecules to and tumor immunity related indicators.
Note: patients being enrolled in part 2 of the study should be those with advanced solid tumor who are suitable for therapeutic regimen of Simmitecan combined with 5 FU/LV as judged by the investigator;
Patients who had failed standard treatments for advanced cancer, or are intolerant to the current standard treatments, or no suitable standard treatments available for advanced cancer;
Patients who have at least one measurable lesion (according to RECIST, version 1.1); note: the lesions previously treated with radiotherapy cannot be regarded as the target lesion, unless the lesion showed clear progression after radiotherapy;
Patients with Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1;
Age≥ 18 years and ≤ 70 years, male or female is allowed;
Patients with life expectancy of 12 weeks or more;
Patients with appropriate organ function as documented by:
Patients with negative hepatitis b surface antigen; for patients with positive hepatitis b surface antigen, quantitative result of hepatitis b virus (HBV) DNA should be lower than 1000 cps/mL;
Toxicity events caused by previous treatments, surgery or radiotherapy have recovered to CTCAE grade 0 or 1 (except for alopecia);
Female patients are eligible for the study if the following conditions are met:
Patients have no fertility (i.e., physiological infertility), including postmenopausal period (complete menolipsis for more than 1 year) or documented irreversible sterilization operation including hysterectomy, bilateral ovariectomy, or bilateral salpingectomy (instead of tubal ligation);
For patients of childbearing potential, the results of serum pregnancy test screening should be negative (within 7 days before the first dose of investigational drug), and breastfeeding is not allowed before the start of the study and throughout the study. Moreover, the patients should agree to take effective contraception measures during the study and within 90 days after the last dose, and should always conduct strict birth control in accordance with the label of drug/appliance and the investigator's instructions. Effective contraception measure is defined as:
Male patients should have undergone vasectomy, or agree to take effective contraception measures during the study and within 90 days after the last dose;
Patients are able to follow the study procedures, restrictions and requirements at the investigator's discretion.
Exclusion criteria
Primary purpose
Allocation
Interventional model
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243 participants in 6 patient groups
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Data sourced from clinicaltrials.gov
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