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Anlotinib hydrochloride combined with chemoradiotherapy in first-line treatment of advanced cervical cancer: a Phase II clinical study.

Anlotinib hydrochloride combined with chemoradiotherapy in first-line treatment of advanced cervical cancer: a Phase II clinical study.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200059335
Enrollment
Unknown
Registered
2022-04-28
Start date
2022-06-01
Completion date
Unknown
Last updated
2024-02-26

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

Conditions

Cervical cancer

Interventions

Test group:Anlotinib with chemoradiotherapy

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. The subjects voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up; 2. Age >= 18 years old (calculated on the day of signing informed consent); 3. Pathologically or histologically confirmed cervical cancer (squamous, adenocarcinoma or adenosquamous) with measurable lesions; 4. Initially diagnosed IVB stage (according to FIGO 2018 staging); 5. ECOG score is 0~2 points; 6. Major organ function meets protocol criteria within 7 days before treatment.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with contraindications to antiangiogenic drugs: 3. Received radiotherapy in the past; 4. Those with high blood pressure that cannot be controlled by treatment; 5. Urine routine shows protein positive++; 6. There are many factors that affect oral drugs (inability to swallow, chronic diarrhea and intestinal obstruction, etc.); 7. Abnormal coagulation function and bleeding tendency: such as active ulcer foci, fecal occult blood (++), etc.; 8. Grade 3-4 cardiac insufficiency (New York cardiac function classification); 9. Patients with severe hepatic and renal insufficiency (grade 4); 10. According to the judgment of the investigator, there are concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study; 11. Expected survival less than 3 months.

Design outcomes

Primary

MeasureTime frame
Objective remission rate, ORR;

Secondary

MeasureTime frame
Overall survival, OS;Progression free survival, PFS;Disease control rate, DCR;

Countries

China

Contacts

Public ContactShoumin Bai

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

smbai999@163.com+86 13802507186

Outcome results

None listed

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