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Perfusion Computed Tomography as Functional Biomarker in Phase II Basket Study of Apatinib in progressed solid tumors after second lined therapy

Perfusion Computed Tomography as Functional Biomarker in Phase II Basket Study of Apatinib in progressed solid tumors after second lined therapy

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021799
Enrollment
Unknown
Registered
2019-03-10
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-03-11

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

Conditions

solid tumor

Interventions

Case series:apatinb

Sponsors

Ruijin Hospital, Shanghai JiaoTong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patient volunteered to participate in the study and signed an informed consent form; 2. The solid tumors must be confirmed by pathology,which have at least one measurable lesion with a diameter of =3 cm; the above pathological diagnosis must be made by Ruijin Hospital; 3. Patients who have failed at least two chemotherapy regimens in the last 6 months; [Note: Treatment failure refers to disease progression or intolerance during treatment or within 3 months of the last treatment]. 4. Aged 18-70 years old; ECOG PS score: 0~1 points; expected survival period is more than 3 months; 5. Previously used targeted drugs with different mechanisms of action of apatinib such as everolimus and TKI. It is admitted that previously used similar to apatinib but with less than 2 weeks and discontinued for more than 1 month Patient; 6. The main organ function meets the following criteria within 7 days before treatment: (1) Blood routine examination criteria (without blood transfusion within 14 days): hemoglobin (HB) = 80g/L; neutrophil absolute value (ANC) = 1.5 × 10^9/L; platelets (PLT) = 70 × 10^9/L; (2) Biochemical examinations must meet the following criteria: total bilirubin (TBIL) = 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase AST = 2.5 ULN, such as with liver metastasis, ALT and AST = 5 ULN; serum creatinine (Cr) = 1.5 ULN or creatinine clearance (CCr) = 60ml/min; 7. Women of childbearing age should agree to use contraceptives (such as intrauterine devices, contraceptives or condoms) during the study period and within 6 months after the end of the study; negative serum or urine pregnancy tests within 7 days prior to study enrollment, It must be a non-lactating patient; men should agree to patients who must use contraception during the study period and within 6 months of the end of the study period.

Exclusion criteria

Exclusion criteria: 1. Patients with hypertension who are unable to reach the normal range with antihypertensive drugs (systolic blood pressure >140 mmHg, diastolic blood pressure > 90 mmHg), have coronary heart disease = grade II, arrhythmia (including QTc interval prolongation, male > 450 ms, female > 470 ms) and cardiac insufficiency; 2. A variety of factors that affect the absorption of oral medications (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction); 3. Special Note: Patients with a risk of gastrointestinal bleeding may not be enrolled, including the following: (1) active digestive ulcer lesions and fecal occult blood (++); (2) melena and hematemesis within 3 months History of the disease; (3) for fecal occult blood (+) must be performed a gastroscopy to determine whether there is a gastrointestinal organic disease; 4. abnormal blood coagulation (INR > 1.5×ULN, APTT > 1.5×ULN), with bleeding tendency; 5. Those who are allergic to any of the ingredients should be banned; 6. Have active bleeding, within 30 days after major surgery; 7. Intracranial transfer; 8. Pregnant or lactating women; 9. Within 3 weeks after the last systemic cytotoxic drug treatment and radiotherapy; 2 or more targeted drugs were taken, or other targeted drugs were taken 3 weeks before the group; 10. Other malignant tumors have occurred in the past 3 years; 11. The investigator believes that there are any conditions that may damage the subject or result in the subject not being able to meet or perform the research request.

Design outcomes

Primary

MeasureTime frame
progression free survival;

Secondary

MeasureTime frame
over survial;safety;

Countries

China

Contacts

Public ContactJun Zhang

Ruijin Hospital, Shanghai JiaoTong University, School of Medicine

junzhang@188.com+86 13818332497

Outcome results

None listed

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