UnknownPhase 2

Nab-PTX, Ifosfamide and Cisplatin in the Treatment of Pediatric Extracranial Germ Cell Tumor.

43 participantsStarted 2020-11-10

Plain-language summary

The purpose is to evaluate the effectiveness and safety of albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin in the treatment of children patients with advanced, recurrent or refractory extracranial germ cell tumor.

Who can participate

Age range1 Year – 18 Years

SexALL

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Inclusion criteria

✓. Age: 1-18 years old;
✓. ECOG PS score: 0-1;
✓. Patients was confirmed pathologically with malignant germ cell tumor.
✓. Patients with tumor progressed, relapsed or refractory after first-line chemotherapy, and complete or partial remission was not achieved after recent treatment.
✓. Have at least one measurable lesion defined by RECIST standard;
✓. The estimated survival time was more than 6 months;
✓. Patients must fully recover from the acute toxicity of previous anticancer chemotherapy:
✓. Bone marrow function met the following criteria:

Exclusion criteria

✕. Patients with recurrent germ cell tumor were treated by surgery alone previously;
✕. Patients with immature teratoma (any grade);
✕. Patients with sex cord stroma;
✕. HBsAg positive patients;
✕. Patients with HIV or syphilis infection;
✕. Patients who had received organ transplantation before;
✕. Uncontrolled active systemic bacterial, viral or fungal infections;

What they're measuring

overall response rate，ORR

Timeframe: From the beginning of observation to the 2 cycles of observation(each cycle is 21 days)

Trial details

NCT IDNCT04581265

SponsorSun Yat-sen University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-10

Contact for this trial

Yizhuo Zhang

020-87342459 zhangyzh@sysucc.org.cn

View on ClinicalTrials.gov More Extracranial Germ Cell Tumor, Pediatric trials