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Clinical study on the efficacy and safety of arotinib hydrochloride in the treatment of advanced solid tumors in the real world

Clinical study on the efficacy and safety of arotinib hydrochloride in the treatment of advanced solid tumors in the real world

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046369
Enrollment
Unknown
Registered
2021-05-15
Start date
2021-05-15
Completion date
Unknown
Last updated
2021-12-21

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

Conditions

Advanced solid tumor

Interventions

lung cancer Group:According to the study protocol
colorectal cancer group:According to the study protocol
esophageal cancer group:According to the study protocol
liver cancer group:According to the study protocol
Gynecological tumor group:According to the study protocol
mammary cancer group:According to the study protocol
renal carcinoma group:According to the study protocol
Other advanced solid tumors group:According to the study protocol

Sponsors

People's Hospital of Ruyang County
Lead Sponsor

Eligibility

Sex/Gender
All
Age
12 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. The patient voluntarily participated in this study, signed an informed consent form, had good compliance, and cooperated with the follow-up; 2. Aged 12-85 years, no gender limit; 3. Diagnosed as malignant tumor by histopathology and immunohistochemical examination; 4. PS = 12 weeks 6. Patients with advanced solid tumors diagnosed pathologically, regardless of the type of cancer, have at least one measurable lesion; 7. There are no serious uncontrollable metabolic aspects, infections or neurological diseases; 8. Excluding other malignant tumors.

Exclusion criteria

Exclusion criteria: 1. Those who have been confirmed to be allergic to Anlotinib Hydrochloride and/or its excipients; 2. Suffering from uncontrollable hypertension (systolic blood pressure> 140mmHg, diastolic blood pressure> 90mmHg, despite the best medical treatment), suffering from myocardial ischemia or myocardial infarction above grade II, poorly controlled arrhythmias (including QTc (Male >=450ms, female >=470ms); according to NYHA standards, grade III-IV cardiac insufficiency, or cardiac color Doppler ultrasound examination revealed left ventricular ejection fraction (LVEF) 1.5, APTT>1.5ULN), with bleeding tendency; 5. There are many factors that affect the absorption of oral drugs (such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 6. Patients whose tumors have invaded important blood vessels or the investigator judges that hemorrhage may occur during the follow-up study; 7. Pregnant or lactating women; 8. Infectious wounds prolonged and unhealed; 9. According to the investigator's judgment, patients with concomitant diseases that seriously endanger the safety of the patient or affect the patient's completion of the study.

Design outcomes

Primary

MeasureTime frame
Disease progression-free survival;

Secondary

MeasureTime frame
Objective response rate;Disease control rate;Quality of Life;Overall survival;

Countries

China

Contacts

Public ContactWu Yongfei

People's Hospital of Ruyang County

wyf158379@126.com+86 15837991680

Outcome results

None listed

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