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Clinical study of hydrochloride anlotinib combined with concurrent radiochemotherapy for locally advanced (stage IIB-IVA) cervical squamous cell carcinoma

Clinical study of hydrochloride anlotinib combined with concurrent radiochemotherapy for locally advanced (stage IIB-IVA) cervical squamous cell carcinoma

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036084
Enrollment
Unknown
Registered
2020-08-21
Start date
2021-01-01
Completion date
Unknown
Last updated
2021-01-25

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

Conditions

Cervical cancer

Interventions

Case series:Radiotherapy + Concurrent chemotherapy + Anlotinib

Sponsors

Zhongnan Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Volunteer to participate and sign written informed consent; 2. Aged 18-75 years old; 3. Histologically confirmed cervical squamous cell carcinoma; 4. Clinical stage IIB-IVA stage; 5. Initial treatment (never received radiotherapy, chemotherapy, molecular targeted drugs and other anti-tumor treatments before); 6. The primary tumor can be measured; 7. No distant organ metastasis; 8. The Karnofsky score >70; 9. Survival expected >=3 months; 10. Women during the reproductive period should ensure contraception during the study period; 11. Hemoglobin >=100 g/L, WBC >=4x10^9/L, platelet >=100x10^9/L; 12. Liver function: ALT, AST50%, the percentage of DLCO (lung diffusion function) measured value and predicted value>80%; 15. The patient has good compliance with the treatment and follow-up.

Exclusion criteria

Exclusion criteria: 1. There is evidence of distant organ metastasis; 2. The primary tumor or lymph nodes have been treated with surgery (except for biopsy); 3. The primary tumor or lymph node has received radiotherapy, chemotherapy, and molecular targeted therapy; 4. Other malignant tumors were diagnosed 5 years before the start of this study (except for cured in situ cervical cancer/basal cell carcinoma of the skin/bladder epithelial tumor); 5. Subjects who have undergone other drug trials in the past month; 6. Pregnant or breastfeeding women and women who refuse contraception during the treatment observation period; 7. People with a history of severe allergies or idiosyncratic physique; 8. People with a history of severe lung or heart disease; 9. Refusal or inability to sign informed consent to participate in the trial; 10. People who abuse drugs or alcohol; 11. Persons with personality or mental illness, without or with limited capacity for civil conduct.

Design outcomes

Primary

MeasureTime frame
3 years overall survival;2 years overall survival;3 years progression free survival;2 years progression free survival;3 years local control rate;2 years local control rate;

Secondary

MeasureTime frame
acute adverse events rate;chronic adverse events rate;

Countries

China

Contacts

Public ContactHui, Qiu

Zhongnan Hospital of Wuhan University

qiuhuiznyy@whu.edu.cn+86 18986255160

Outcome results

None listed

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