Status and phase
Conditions
Treatments
About
A total of 40 subjects who had not received systemic treatment or chemotherapy in the past and were allowed to receive adjuvant or neoadjuvant treatment for advanced melanoma received tirelizumab combined with dacarbazine for 4-6 cycles to evaluate the efficacy, safety and prognosis of tirelizumab combined with dacarbazine in the treatment of advanced melanoma.
Full description
In henan province tumor hospital into the group of 40 cases always will not accept any systemic therapy or chemotherapy, allowed to always have a recurrence of adjuvant or neoadjuvant therapy sensitive sensitive relapse (referring to more than six months after the last chemotherapy recurrence) of unresectable melanoma metastatic/operation subjects, accept for LeiLiZhu a joint resistance of kappa oxazine treatment 4-6 cycles, To evaluate the efficacy, safety and prognosis of tislelizumab combined with dacarbazine in the treatment of advanced melanoma.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Male or female patients aged 18-72 years (inclusive);
patients with unresectable stage III or IV melanoma diagnosed histologically or cytologically;
According to the efficacy evaluation criteria for solid tumors (RECIST V1.1), there are lesions that can be used as target lesions for evaluation;
Prior adjuvant or neoadjuvant therapy must have been completed for at least 4 weeks prior to study drug administration, and all associated toxic effects (except hair loss) have been recovered (to ≤ class 1 or baseline) prior to study drug administration;
ECOG score was 0-1;
The expected survival time is more than 3 months;
No major surgery (except for baseline tumor biopsy) or severe trauma occurred at least 14 days prior to the first administration of study therapy;
Adequate organ and bone marrow function, as defined below:
Blood routine (no blood transfusion, no G-CSF, no drug correction within 14 days prior to screening) Neutrophil count (ANC) ≥ 1,500/mm3 (1.5 × 109 /L); Platelet count (PLT) ≥ 100,000/mm3 (100 × 109 /L); Hemoglobin (Hb) ≥ 9 g/dL (90 g/L); Blood biochemical Serum creatinine (Cr) ≤ 1.5× upper limit of normal (ULN) or creatinine clearance Rate (Cockroft-Gault formula) ≥ 60 mL /min; Total bilirubin (TBIL) ≤ 1.5×ULN; Aspartate aminotransferase (AST) or ALT ≤2.5×ULN, Subjects with liver metastasis should be ≤5×ULN; Blood coagulation function International standardized ratio (INR) ≤1.5, prothrombin time (PT) and Activated partial thrombin time (APTT) ≤1.5×ULN; Routine urine urinary protein <2+; If urinary protein ≥2+, 24 hours of urinary protein quantitative significant Protein must be ≤1g; Thyroid function Thyroid stimulating hormone (TSH) ≤ ULN; If abnormal, FT3(T3) should be investigated.
And FT4(T4), and normal FT3(T3) and FT4(T4) levels could be selected;
Female subjects of reproductive age must have performed a serological pregnancy test within 7 days prior to medication, with negative results, and be willing to use a medically approved highly effective contraceptive method (e.g., an intrauterine device, birth control pill, or condom) during the study period and for 3 months after the last medication; For male subjects with a female partner of reproductive age, surgical sterilization or consent was required during and after the study
Able to understand and voluntarily sign written informed consent;
Subjects must be willing and able to complete study procedures and follow-up examinations.
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
40 participants in 1 patient group
Loading...
Central trial contact
Wang Jiaqiang, Dr.
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal