Anlotinib combined with radiotherapy versus sigio combined with radiotherapy in the treatment of advanced and medium senile esophageal carcinomar

Androtinib hydrochloride combined with radiotherapy versus sigio combined with radiotherapy in the treatment of advanced and medium senile esophageal carcinomar

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100051904

Enrollment

Unknown

Registered

2021-10-09

Start date

2021-12-01

Completion date

Unknown

Last updated

2022-06-27

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

Conditions

esophageal cancer

Interventions

Experimental group:Anlotinib hydrochloride capsule combined with radiotherapy

Control group:Sigio combined with radiotherapy

Eligibility

Sex/Gender

All

Age

70 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1.Patients with esophageal squamous cell carcinoma confirmed by histopathology; 2.Patients whose clinical stage is cT1b-T4b N0-N+, which is judged as medically unresectable or unresectable by a multidisciplinary team of clinicians or who refuses surgery; 3.According to RECIST version 1.1 of the Response Evaluation Criteria for Solid Tumors, at least one measurable lesion; The measurable lesion has not received local treatment such as radiotherapy; 4.Aged 70 to 85 years, male or female patients; 5.ECOG PS score 0~2; expected survival period >= 36 months; 6.Has adequate organ and bone marrow function; 7.Patients with esophageal squamous cell carcinoma who can accept chemotherapy or oral chemotherapy.

Exclusion criteria

Exclusion criteria: 1.Patients with active bleeding within 2 months of the primary lesion, or patients with esophageal squamous cell carcinoma confirmed by biopsy that invaded the tracheobronchial or tracheoesophageal fistula; 2.Patients with multiple factors that affect the absorption of oral drugs (such as after gastrointestinal resection, chronic diarrhea and intestinal obstruction, etc.); 3.Allergic to the raw materials and excipients of sigio and anlotinib; 4.Patients with esophageal squamous cell carcinoma who have a stent placed in the esophagus and are judged by the researchers to be prone to bleeding; 5.Doctors evaluate patients with esophageal fistula or bleeding risk for esophageal squamous cell carcinoma patients who cannot receive radiotherapy, such as patients with deep esophageal ulcers, mediastinal fistulas or hematemesis; 6.Patients who have previously received radiotherapy to the same part of the esophagus.

Design outcomes

Primary

Measure	Time frame
1-year locoregional recurrence-free survival;	—

Secondary

Measure	Time frame
Progression-free survival;Objective remission rate;Overall survival;Disease Control Rate;Security;	—

Countries

China

Contacts

Public ContactZhao Lina

The First Affiliated Hospital of Air Force Military Medical University

zhaolinazln@outlook.com+86 13572553455

Outcome results

None listed

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