Relapsed and refractory advanced male germ cell tumor
Conditions
Interventions
treatment group:Gemcitabine:800 mg/m2, ivgtt, d1, d8,every 3 weeks
Oxaliplatin:130mg/m2, ivgtt, d8,every 3 weeks
Eribulin:1.4mg/m2, ivgtt, d1, d8,every 3 weeks
PEG-GCSF:6mg,H,d9,every 3 weeks
Up to 6 courses or until disease progression or intolerable toxicity.
Sponsors
Sun Yat-sen University Cancer Center
Eligibility
Sex/Gender
Male
Age
16 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Male,= 16 years old. 2. Confirmed recurrent or metastatic germ cell tumor, including seminoma, non-seminoma or mixed type of histopathology, primary gonadal or extraneous primary; 3.Progression, drug resistance, or intolerance to cisplatin-containing regimentation, including any of the following: ?tumor progression after two-line cisplatin-containing combination regimentation;?Tumor progression during the first-line combination regimen containing cisplatin or within 3 months of withdrawal; ? Ineligible for cisplatin chemotherapy due to poor renal function or other reasons; 4.Tumor progression or recurrence after high dose salvage chemotherapy supported by autologous stem cells was allowed; 5.Having radiographically measurable lesions or tumor markers AFP or ßHCG increased by at least 25% in the 3 weeks prior to study inclusion, and exclude elevated tumor markers from other non-germ cell tumor causes; 6.Previous radiation therapy for the disease (retroperitoneal lesions/brain metastases) is allowed, but the radiation-related toxicity must be restored to less than 1 degree; 7.ECOG scores =1; Life expectancy > 3 months; 8.No history of serious heart, lung, liver or other important organ diseases; Good bone marrow, liver, kidney, and heart function: ?Bone marrow function requirements: hemoglobin (Hb) =90 g/L, white blood cell count (WBC) =3.0×109/L, neutrophil count (ANC) =1.5×109/L, platelet count (PLT) =100×109/L; ?Liver function: In patients without liver metastasis, glutamic oxalic aminotransferase (AST),glutamic pyruvic aminotransferase (ALT),alkaline phosphatase (ALP) =2.5 times the upper limit of normal value; In patients with liver metastasis, AST, ALT, ALP=5 times the upper limit of normal values. Total bilirubin =1.5 times upper limit of normal value; ?Renal function: serum creatinine =1.5 times upper limit of normal L or creatinine clearance =50mL/min; ?Cardiac function: no history of heart disease, LVEF = 50%; 9.Patients with reproductive function need to use effective contraception during treatment; 10. Patients understand the study procedures and sign the written informed consent form to express his agreement to participate in the research.
Exclusion criteria
Exclusion criteria: 1.Female germ cell tumor; 2.The pathological type was pure teratoma; 3.Previous use of regimens containing gemcitabine, oxaliplatin or eribulin; 4.Patients are participating in other interventional clinical studies or less than 4 weeks from the end of treatment in the previous clinical study; 5.Patients whose antitumor treaty-related adverse reactions (except alopecia) did not recover to NCI-CTCAE= class 1 after previous systemic treatment; 6.Patients with symptomatic brain metastases; 7.Other active malignancies requiring simultaneous treatment; A history of malignancy,The exceptions are basal cell carcinoma of the skin, superficial bladder cancer, and squamous cell carcinoma of the skin, which have been treated with potentially curable therapy and are free of disease recurrence for 5 years after the end of treatment; 8.Participants who had undergone major surgery or severe trauma had less than 14 days of removal of the effects of surgery or trauma prior to enrollment; 9.With other serious, poorly controlled concomitant diseases that may be aggravated by combination chemotherapy, including but not limited to the following: ?A history of clinical symptoms of cardiovascular, liver, respiratory, kidney, blood endocrine system, or neuropsychiatric disorders; ?Severe acute or chronic infection requiring systemic treatment, active infection occurring 2 weeks before enrollment, requiring antibiotic treatment; ?Patients with active pulmonary tuberculosis; 10.Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS); 11.Persons who have received live vaccine within four weeks prior to the administration of the investigational drug, receive inactivated virus vaccine for seasonal influenza by injection are allowed but not live attenuated influenza vaccine for intranasal use; 12.Active hepatitis,untreated active hepatitis B.Note: Subjects having hepatitis B who met the following criteria were also eligible for inclusion: ?HBV viral load must be <1000 copies /ml prior to initial dosing, and subjects should receive anti-HBV therapy throughout the study to avoid viral reactivation;?Subjects with anti-HBC (+), HBsAg (-), anti-HBS (-) and HBV viral load (-) do not need to receive prophylactic anti-HBV therapy, but need to closely monitor viral reactivation; 13.Allergy to any investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| favorable best response rate,FBRR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate, ORR;progression-free survival ,PFS;Overall Survival, OS;Toxicity;Assessment of patients' quality of life; | — |
Countries
CHINA
Contacts
Public ContactShi Yanxia
Sun Yat-sen University Cancer Center
Outcome results
None listed