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Clinical study of thalidomide combined with chemotherapy in the treatment of relapsed or refractory yolk sac tumor in children

Clinical study of thalidomide combined with chemotherapy in the treatment of relapsed or refractory yolk sac tumor in children

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200061195
Enrollment
Unknown
Registered
2022-06-15
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

yolk sac tumor

Interventions

one:Oral thalidomide combined with TGA chemotherapy

Sponsors

Affiliated Cancer Hospital of Shandong First Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. The child must have histological evidence of extracranial malignant germ cell tumor (yolk sac tumor); 2. When participating in the study, the age of the children must be less than 18 years old; 3. Children with yolk sac tumor who were drug resistant after at least two platinum-containing chemotherapy regiments or had relapsed within 3 months after chemotherapy, or had relapsed after sirolimus combined with TIC chemotherapy regiments; 4. The child must have a measurable lesion (as recorded by RECIST criteria) or an unevaluable disease with a tumor marker AFP greater than 5 times the upper limit of normal; 5. Lansky performance state score >= 50; 6. The child must have a life expectancy of more than six weeks; 7. The child must have recovered from all previous responses to anticancer therapy; 8. No serious organ dysfunction: normal cardiac function (cardiac ejection fraction > 50% or BNP < 2000 pg/ml); Liver function: the elevation of alanine aminotransferase was less than 5 times of the upper limit of normal value, and bilirubin was less than 3 times of the upper limit of normal value; Renal function: creatinine and urea nitrogen levels below the normal range; In blood routine, white blood cells were larger than 3 x10^9/L and platelets were larger than 100 x 10^9/L; 9. Obtain the guardian informed consent and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with other tumors; 2. Patients with heart, brain, liver, kidney and other organ failure.

Design outcomes

Primary

MeasureTime frame
Medical images;

Countries

China

Contacts

Public ContactYixiang Song

Affiliated Cancer Hospital of Shandong First Medical University

syx12319@126.com+86 18678869301

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026