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A pilot study for detection of safety and effect of Combretastain A4 phosphate injection combined with paclitaxel, Carboplatin in the treatment of head and neck advanced solid tumor

A pilot study for detection of safety and effect of Combretastain A4 phosphate injection combined with paclitaxel, Carboplatin in the treatment of head and neck advanced solid tumor

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-13003700
Enrollment
Unknown
Registered
2013-10-12
Start date
2013-10-16
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

Head and Neck advanced solid tumor

Interventions

one cohort:CA4 combined with TC

Sponsors

Tianjin City Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Confirmed by histological or cytological diagnosis head and neck solid tumor, but unable to resection, or residual tumor, or failure to be treated by routine therapy (include I 131) tumor, relapsed tumor; 2. Distant metastasis (clinical phase IVc) and has to be confirmed there is original nidus or metastasis nidus of head and neck advanced solid tumor; 3. Immage shows the tumor not obviously pressure on airway or accepted airway fistulation, without moderate or severe swallow/respiratory difficulty; 4. There is tumor nidus according to RESIST 1.1 standard; 5. Aged 18 to 65 years, both gender; 6. ECOG scores 0-1, prospected survival longer than three months; 7. At least four weeks from last chemo- or radiotherapy except non nidus radiotherapy; 8. Blood pressure=50%; 9. Kidney function, liver function, electrolyte fall in normal range; Neutrophil count>=1.5*10^9/L (Cell growth factor not used), Plt>=100*10^9/L; Hb>=8.5g/dl; 10. Pregnancy urine test negative before one week of enrollment; childbearing age women agree to use validity method to contraception at the duration of before study, in the study process until six months after stop treatment (the contraception method should be recorgnized by investigators); 11. To be able to understand the research and willing sign informed consent.

Exclusion criteria

Exclusion criteria: 1. With head original tumor or/and metastasis tumor; 2. Allergic against paclitaxel, Carboplatin; 3. Suffered cerebral infarction or/and cerebral ischemia attack or with cerebral hemorrhage history in past six months; 4. coronary heart disease (AMI history, or positive on Coronary angiography, or confirmed by coronary CT test, or by movement experiment, or typical angina history), NYHA III or IV Congestive heart failure; 5. malignant arrhythmia (torsade heartbeat tachycardia, above LOWN grade III ventricular premature beats, ventricular heartbeat tachycardia, ventricular fibrillation) or congenital long QT syndrome; 6. Slow arrhythmia, include sinus bradycardia (<60/min.), or above II grade heart block, or sinus arrest (except installated pacemakers); 7. ECG found clinical meanable ventricular arrhythmia, new ST segment elevation or depression, or appear Q waves; 8. Have to use any known extent QTc interval drugs, include anti arhythmia; 9. Blood presure higher <90/60 mmHg; 10. Syncope or / and epilepsy history; 11. aneurysm history; 12. psychopathy history; 13. Peripheral nervous system diseases, Limb muscle strength III grade and above; 14. ataxia; 15. Sensory dysfunction of peripheral neuropathy; 16. Solid organ or bone marrow transplantation patient; with other tumor except treated Cervical carcinoma in situ and skin basal cell carcinoma; 17. Attented other clinical trial or investigational therapy; 18. To be considered not suitable to attend this study.

Design outcomes

Primary

MeasureTime frame
RECIST 1.;CT or MRI;

Countries

China

Contacts

Public ContactGAO MING

Tianjin City Cancer Hospital

gaoming68@aliyun.com+86 18622221110

Outcome results

None listed

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