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Clinical study of sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children

Clinical study of sirolimus combined with chemotherapy in the treatment of recurrent/refractory yolk sac tumor in children

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000040419
Enrollment
Unknown
Registered
2020-11-28
Start date
2020-12-01
Completion date
Unknown
Last updated
2021-02-22

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

Conditions

Yolk sac tumor

Interventions

Case series:Sirolimus +TIC chemotherapy regimen

Sponsors

Shandong Cancer Hospital and Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 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 children must be no more than 14 years old; (3) Children must have drug resistance after at least two platinum-based chemotherapy regiments or relapse within 3 months after chemotherapy; (4) The child must have a measurable lesion (recorded according to RECIST criteria) or an unevaluable disease with a tumor marker AFP >=5 ULN; (5) Lansky performance status score >=50; (6) The child's life expectancy must exceed 6 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 < 2000pg/ml); Liver function: alANINE aminotransferase in the upper limit of the normal value of 5 times below, bilirubin in the upper limit of the normal value of 3 times below; Renal function: creatinine, urea nitrogen levels below the normal range; White blood cells and platelets were greater than 3x10^9/L and 100x10^9/L respectively; (9) Obtain and sign an informed consent form from the guardian.

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
The sum of the longest diameters of all target lesions;

Countries

China

Contacts

Public ContactWang Jingfu

Shandong Cancer Hospital and Institute

wangjingfu@yahoo.com.cn+86 17653115537

Outcome results

None listed

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