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Individualised therapy guided by MiniPDX and K cell FGI analysis for refractory soft tissue sarcoma: a prospective, randomized clinical study in a single institute.

Individualised therapy guided by MiniPDX and K cell FGI analysis for refractory soft tissue sarcoma: a prospective, randomized clinical study in a single institute.

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037359
Enrollment
Unknown
Registered
2020-08-28
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

soft tissue sarcoma

Interventions

experimental group:Individualized second-line therapy based on minipdx / FGI Technology
control group:Conventional second-line treatment

Sponsors

Shanghai Sixth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The patients voluntarily participated in the study, signed the informed consent, and had good compliance and cooperated with the follow-up; 2. The final pathological type was confirmed by pathology department of Shanghai Sixth People's hospital; 3. There is no indication of surgical treatment for the target lesion or the patient refuses to operate; 4. Patients who have used at least one first-line regimen for treatment failure or intolerance in the last 6 months; 5. Aged 18-70 years; 6. ECoG PS score: = 80g / L; 2) The absolute value of neutrophil (ANC) >=1.5 x 10^9 / L; 3) Platelet (PLT) >= 80 x 109 / L. (2) Biochemical examination should meet the following standards: 1) Total bilirubin (TBIL) = 60 ml / min. 9. Women of childbearing age should agree that contraceptive measures (such as intrauterine device, contraceptive or condom) must be used during the study period and within 6 months after the end of the study; serum or urine pregnancy test negative within 7 days before study enrollment, and must be non lactating patients; men should agree that contraceptive measures must be used during the study period and within 6 months after the end of the study period.

Exclusion criteria

Exclusion criteria: 1. Patients with hypertension, who can not keep stable after regular blood pressure lowering therapy, have coronary heart disease (CHD) of grade II, arrhythmia (including QTc interval prolongation, male > 450 ms, female > 470 MS) and cardiac dysfunction; 2. Abnormal coagulation function (INR > 1.5 x ULN, APTT > 1.5 x ULN) with bleeding tendency; 3. Active bleeding within 30 days after major operation; 4. Intracranial metastasis; 5. Pregnant or lactating women; 6. Other malignant tumors in the past three years; 7. The researcher believes that there is any condition that may damage the subject or cause the subject to be unable to meet or perform the research requirements.

Design outcomes

Primary

MeasureTime frame
Progression Free Survival, PFS;

Secondary

MeasureTime frame
Overall Survival, OS;Objective Response Rate, ORR;Duration of Response, DOR;Disease Control Rate, DCR;

Countries

China

Contacts

Public ContactShen Zan

Shanghai Sixth People's Hospital

sshenzzan@vip.sina.com+86 18930177014

Outcome results

None listed

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