Not Yet RecruitingPhase 2

Study of Precision Treatment for Rare Tumours in China Guided by PDO and NGS

200 participantsStarted 2025-01-01

Plain-language summary

The objective of this Phase II, open-label, multicenter, non-randomised controlled clinical trial is to guide precision treatment for patients with rare tumours based on Patient-Derived Organoids/Next-Generation Sequencing drug screening.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Male or female, the age at the time of signing the informed consent is no less than 18 years old;
✓. Patients with advanced or metastatic rare solid tumor confirmed by histological confirmed;
✓. ECOG score is 0 or 1;
✓. Expected survival ≥12 weeks;
✓. According to Response Evaluation Criteria in Solid Tumor (RECIST 1.1), there is at least one imaging measurable lesions, which has not previously undergone radiotherapy or with obvious disease progress after radiotherapy;
✓. Surgical specimens of paired tumor tissue and adjacent normal tissue, or fresh biopsy tissue samples or ≥500ml serous cavity effusion with positive pathological cytological examination must be provided. These specimens must be obtained without prior exposure to any other anti-tumor treatment, systemic anti-infection treatment, vaccination, et al. and are intended for organoid culture;
✓. Must have a primary or metastatic paraffin-embedded tissue (without radiotherapy) other than bone metastatic lesions before enrollment (within 2 years, 15-20 sheets, 4-6μm thick white slices, of which 5 need to be glued and baked ) and peripheral blood samples for NGS gene testing. If NGS results are already available but sufficient paraffin-embedded tissue cannot be provided, investigator are allowed the decision to enroll subjects according to the specific situation;
✓. In the condition that the primary lesions biopsy specimen has been provided, if the metastatic lesion is able to be biopsied(determined by investigator), it is suggested to keep the specimen for pathological testing and provide fresh tissue specimen;

Exclusion criteria

✕. No patient lesions available for organoid model construction;
✕. History of interstitial lung disease or radiation pneumonitis of any type;
✕. Central Nervous System (CNS) metastases with brain metastases-related symptoms, which is not stable in neurology, or need to increase steroid dosage to control CNS disease. (Note: Patients with controlled CNS metastasis are eligible to participate in this study);
✕. Current uncontrollable third cavity effusion, such as a large amount of pleural effusion，ascites , or pericardial effusion;
✕. Major surgical operations or incomplete healing of injury within 4 weeks prior to study treatment\'s first administration and chest radiotherapy of \> 30 Gy within 6 months;
✕. History of receiving other investigational drugs within 14 days or 5 half-lives (whichever is longer) prior to the first administration;
✕. History of receiving live vaccine within 30 days prior to the first administration. Seasonal influenza vaccines that do not contain live viruses are allowed;
✕. Current active infection requiring systemic treatment (antibiotics); or any of the following:

What they're measuring

Objective Response Rate (ORR)

Timeframe: From enrollment to the end of treatment at 8 weeks

Trial details

NCT IDNCT06692491

SponsorPeking University Shenzhen Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

shubin wang, Doctor

+86 13823394076 wangshubin2013@163.com

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