Recurrent or refractory extracranial germ cell tumors in children or adolescents
Conditions
Interventions
The TGA combined with thalidomide treatment group:Thalidomide combined with the TGA regimen (albumin-bound paclitaxel + gemcitabine + epirubicin) for treatment
TGA treatment group:TGA regimen (albumin-bound paclitaxel + gemcitabine + epirubicin) for treatment
Sponsors
Shandong First Medical University Affiliated Cancer Hospital
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1.Histological or cytological diagnosis of extracranial germ cell tumors. 2.Meets the clinical diagnostic criteria and is diagnosed as a patient with recurrent/refractory extracranial germ cell tumors. Definition of recurrence: After at least one line of standard treatment, the patient achieves complete remission and the disease is confirmed after the end of treatment; Definition of refractoriness: At least 4 cycles of first-line chemotherapy have been used, and according to the efficacy evaluation criteria for solid tumors (RECIST 1.1), the disease progresses or is defined as disease progression in the "Clinical Practice Guidelines for Children with Extracranial Malignant Germ Cell Tumors (2021 Edition)" when the tumor marker increases and persists for 4 weeks. The first-line standard treatment can refer to the "Clinical Practice Guidelines for Children with Extracranial Malignant Germ Cell Tumors (2021 Edition)". 3.The patient must have measurable lesions recorded according to the RECIST 1.1 standard. 4.Age >= 2 years, 12 years) or Lansky score 70-100% (= 12 weeks. 7.Before initiating any project-related procedures, the parents/guardians of the children and adolescents can understand, agree, and sign the research informed consent form (ICF) and the applicable pediatric consent form; the subjects can express their consent (if applicable) with the consent of their parents/guardians. 8.Adequate organ and bone marrow function;
Exclusion criteria
Exclusion criteria: 1.Within the 2 weeks prior to treatment, the following treatments were received: radiotherapy for tumors, chemotherapy, molecular targeted therapy; other clinical research drugs; vaccination with attenuated live vaccines. 2.The cumulative dose of anthracycline drugs received in the past has reached the maximum standard. 3.Patients who received anti-angiogenic targeted drugs such as apatinib, pazopanib, sunitinib, sorafenib, bevacizumab, imatinib, crizotinib, famitinib, anlotinib, regorafenib, vascular endothelial inhibitor, etc. within the past 3 months. 4.Central nervous system metastasis. 5.Within the past 3 months before enrollment, there was a history of thrombosis and the anticoagulant treatment duration was less than 6 weeks. 6.Known bleeding tendency, significant clinical significance of bleeding symptoms occurred within 3 months before treatment or having a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, baseline fecal occult blood ++ or above, vasculitis, etc.; or thromboembolic events occurred within 6 months before treatment, such as cerebral vascular accident (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.; or long-term anticoagulation treatment with warfarin or heparin, or long-term antiplatelet treatment (aspirin >= 300 mg/day or clopidogrel >=75 mg/day). 7.Recent hypertension and proteinuria have not been controlled. And the antihypertensive drug treatment cannot achieve good control (infants > 100/60 mmHg, preschool children ( 110/70 mmHg, school-age children (6-12 years old) > 120/80 mmHg, adolescence and adults > 140/90 mmHg). 8.Use of antiepileptic drugs. 9.Long-term non-healing wounds, ulcers or fractures, having undergone major surgery within 28 days before enrollment or minor surgery within 7 days before enrollment, abdominal fistula, gastrointestinal perforation. 10.Presence of uncontrolled severe infection. 11.Within 6 months before treatment, there was active heart disease, including myocardial infarction, severe/ unstable angina pectoris, etc. Echocardiography left ventricular ejection fraction 450 ms, females > 470 ms). 12.Diagnosis of any other malignant tumor within 3 years before treatment. 13.Known allergy to the study drug or any of its excipients. 14.Human immunodeficiency virus (HIV) infection, active hepatitis B (positive hepatitis B surface antigen and HBV DNA >= 500 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the detection limit of the analytical method). 15.According to the investigator's judgment, patients with large tumors, prone to rupture and bleeding, tumor regression leading to bleeding, etc., have a high risk. 16.According to the investigator's judgment, there are serious diseases that endanger the safety of the subjects, may confuse the research results, or affect the subjects' completion of this study (such as poorly controlled hypertension, severe diabetes, neurological or mental diseases, etc.) or any other conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate,ORR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Event,AE and Serious Adverse Event,SAE;Abnormal laboratory test indicators;Quality of life score,QoL;Disease control rate,DCR; | — |
Countries
China
Contacts
Public ContactWang Jingfu
Shandong First Medical University Affiliated Cancer Hospital
Outcome results
None listed