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Apatinib and radiotherapy Compared with zoledronic acid and radiotherapy Treatment in Patients With bone metastases of Malignant tumor

An prospective, exploratory, randomized, controlled clinical Study of Apatinib combined radiotherapy Compared with zoledronic acid combined radiotherapy Treatment in Patients With bone metastases of Malignant tumor

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-17010456
Enrollment
Unknown
Registered
2017-01-17
Start date
2017-01-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

cancer

Interventions

Test Group:Apatinib, 250 mg po, qd, Local radiotherapy
Control Group:zoledronic acid: 4 mg, iv, Every 4 weeks

Sponsors

Da Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 18 Years to 75 Years men and women; 2. Patients must have histologically confirmed Solid tumor patients (including the stomach or gastroesophageal junction, non squamous adenocarcinoma non-small cell lung cancer, breast cancer, hepatocellular carcinoma (HCC) or other types of solid tumor); 3. Imaging examination confirmed that at least one bone metastatic lesions; 4. ECOG PS0-2 points; 5. Life expectancy =3 months; 6. With normal marrow, liver and renal function; 1) blood routine examination (without blood transfusion during 14 days), HB=90g/L, ANC =1.5×10^9/L, PLT =80×10^9/L; b) Biochemical examination:a total bilirubin (TBil) of =1.5 upper normal limitation (UNL); alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of =2.5 UNL or =5 UNL in case of liver metastasis.creatinine (Cr) of = 1 UNL; a creatinine clearance rate = 50ml/min (Cockcroft-Gault); 7. With written informed consent signed voluntarily by patients themselves; 8. With good compliance and agree to accept follow-up of disease progression and adverse events.

Exclusion criteria

Exclusion criteria: 1. Uncontrolled hypertension (after treatment with antihypertensive drugs cannot reduced to the normal range; 2. Factors affecting the oral medication (e.g. inability to swallow, chronic diarrhea and intestinal obstruction); 3. With potential bleeding risk including: (1) peptic ulcer and fecal occult blood (++); (2) melena or hematemesis history in last 3 months; (3) fecal occult blood (+) or (+/-) and endoscopy showed ulcer or other diseases with bleeding risk; 4. With abnormal coagulation function (INR>1.5 ULN, APTT>1.5 ULN); 5. Patients who manifested arterial/venous thrombus events, e.g.cerebrovascular accident (including transient ischemic attack), deep venous thrombosis and pulmonary embolism, etc., within 12 months before screening; 6. Uncontrolled infection; 7. Pregnant or lactated women; . 8. Other conditions regimented at investigators' discretion.

Design outcomes

Primary

MeasureTime frame
Incidence of bone related events;

Secondary

MeasureTime frame
PFS;OS;safety;

Countries

China

Contacts

Public ContactZhong Zhaoyang

Daping Hospital

winter6868@163.com+86 13883932762

Outcome results

None listed

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