Actively Recruiting
PLATFORM Study of Precision Medicine for Rare Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-02-11
770
Participants Needed
1
Research Sites
411 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A Phase II, open label, non-randomized, multiple-arm, single-center clinical trial in patients with advanced rare solid tumors who failed to standard treatment.
CONDITIONS
Official Title
PLATFORM Study of Precision Medicine for Rare Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older at the time of consent
- Confirmed advanced or metastatic rare solid tumor by tissue diagnosis
- ECOG performance score of 0 or 1 evaluated within 7 days before first treatment
- Expected survival of at least 12 weeks
- At least one measurable lesion by imaging with clear disease progression before or after radiotherapy
- Disease progressed after standard treatment per NCCN or CSCO guidelines, no standard effective treatment, not suitable for standard treatment, or patient refuses standard treatment
- Provide fresh biopsy tissue samples within 12 weeks before first drug use and peripheral blood samples for molecular typing
- Must have primary or metastatic paraffin tissue specimen (without radiotherapy) within 2 years, 15-20 slices, 4-6 micrometers thick
- If pleural or peritoneal effusion present, provide 300 ml samples for pathological cytology
- If metastatic lesion biopsy possible, provide fresh tissue specimen (optional)
- Patients with specific actionable mutations will enroll targeted therapy sub-studies; others will enroll immunotherapy sub-study
- After disease progression, fresh tissue samples should be obtained if possible
- Toxicity from previous treatment recovered to Grade 1 or baseline (except hair loss)
- Negative pregnancy test for women of childbearing potential; all patients agree to use effective contraception during and for 8 weeks after treatment
- Signed informed consent and willingness to follow study and report adverse events
You will not qualify if you...
- Prior treatment with PD-1 or PD-L1 drugs
- Prior treatment with targeted drugs used in this study
- Allergic reactions to study drug ingredients or excipients
- History of interstitial lung disease or radiation pneumonitis
- Unstable brain metastases or requiring increased steroids for CNS disease
- Uncontrolled large pleural effusion or ascites
- Failure to meet sub-study inclusion criteria
- Major surgery or incomplete wound healing within 28 days before first treatment; chest radiotherapy over 30 Gy within 6 months
- Use of other investigational drugs within 14 days or 5 half-lives prior to first dose
- Use of live vaccines within 30 days prior to first dose (except seasonal influenza without live virus)
- Hypersensitivity to study drugs or chemically similar drugs
- Active infection needing systemic treatment or HIV, active hepatitis B or C, active tuberculosis, or positive syphilis antibody
- Uncontrolled systemic diseases including severe mental, neurological, respiratory, cardiovascular, liver, kidney diseases, or uncontrolled severe hypertension
- Myocardial infarction, coronary artery or cerebrovascular events within 3 months
- Diagnosis of another malignant tumor within 5 years (except certain resected carcinomas)
- History of organ transplantation including stem cell transplantation (except corneal or hair transplantation without immunosuppression)
- Significant cardiovascular disease or arrhythmias requiring treatment
- Abnormal heart conduction or QT interval prolongation beyond specified limits
- Left ventricular ejection fraction below 50%
- Abnormal laboratory values indicating inadequate bone marrow or organ function
- History of swallowing dysfunction or gastrointestinal diseases affecting oral drug absorption
- Pregnant or breastfeeding women
- Serious medical or mental illness affecting treatment compliance
- Any other risks deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer hospital Chinese Academy of Medical Sciences
Beijing, China, 100021
Actively Recruiting
Research Team
N
Ning Li, Doctor
CONTACT
S
Shuhang Wang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
17
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