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Phase II trial for radiotherapy and anlotinib in treatment of loco-regional recurrent esophageal squamous cell carcinoma after radical surgery

Phase II trial for radiotherapy and anlotinib in treatment of loco-regional recurrent esophageal squamous cell carcinoma after radical surgery

Status
Recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025752
Enrollment
Unknown
Registered
2019-09-07
Start date
2019-09-04
Completion date
Unknown
Last updated
2019-09-09

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

Conditions

Esophageal cancer

Interventions

Sponsors

Affilated Cancer Hospital of Zhengzhou University/Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 70 years old; (2) (ECOG) score of tumor cooperation group in the eastern United States (Annex 1) 0-1; (3) radical operation for esophageal carcinoma (R0 operation); (4) the patients had not been treated with anti-angiogenic targeted drugs in the past. (5) the recurrent site had not received neoadjuvant or adjuvant radiotherapy; (6) Local recurrence after operation, which was defined as anastomotic site, lymph node and tumor bed within the horizontal range from cricothyroid membrane to celiac trunk; (7) the number of lesions was less than 3, which was measured by RECIST standard (Response Evaluation Criteria in Solid Tumors, RECIST, Version 1.1); (8) leukocytes >=3.0x10^9 or neutrophils >=1.5x10^9; hemoglobin >=90 g/L; platelet count >=100x10^9; total bilirubin 3 months; (11) have a full understanding of this study, have the ability to complete the treatment, and have the conditions for follow-up to sign the informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: (1) A history of malignant tumors in other parts (previous or simultaneous), excluding curable non-melanomatous skin cancer and cervical carcinoma in situ (survival without disease progression for at least 3 years); (2) patients with distant metastasis; (3) has received anti-angiogenic targeted drug therapy in the past; (4) pregnant and lactating patients; (5) patients with uncontrolled diabetes, hypertension, coronary heart disease and abnormal renal function; (6) there is a tendency of bleeding or perforation, or there is a hemorrhagic disease; (7) the recurrent site was treated with radiotherapy; (8) chemotherapy was received after local recurrence, and the chemotherapy was effective. (9) oral or intravenous administration of hormones at the same time; (10) active infection; (11) hyperarteriovenous thrombosis occurred within 6 months, such as cerebrovascular accident (including temporary ischemic attack), deep venous thrombosis and pulmonary embolism; (12) there are situations in which other researchers believe that this clinical study cannot be completed.

Design outcomes

Primary

MeasureTime frame
Objective response rate and toxicity;

Countries

China

Contacts

Public ContactHong Ge

Affilated Cancer Hospital of Zhengzhou University

gehong666@126.com+86 0371-655877713

Outcome results

None listed

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