NCT05262335

Anlotinib Plus Chemotherapy as First-line Therapy for Gastrointestinal Tumor Patients With Unresectable Liver Metastasis (ALTER-G-001)

Anlotinib Plus Chemotherapy as First-line Therapy for Gastrointestinal Tumor Patients With Unresectable Liver Metastasis: A Multi-cohort, Multi-center Clinical Trial (ALTER-G-001)

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 116 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open, multi-cohort, multi-center, exploratory and phase II clinical trial. To evaluate the efficacy and safety Anlotinib combined with chemotherapy as first-line and maintenance therapy for Gastrointestinal Tumors with Unresectable Liver Metastases.

Conditions

• Gastrointestinal Tumors

Interventions

Type	Name	Description
DRUG	Anlotinib + Oxaliplatin + Capecitabine	1. Before 6 cycles, Anlotinib 12mg, po.qd, d1-14; Capecitabine 850 mg/m2, po. bid, d1-14; Oxaliplatin 130 mg/m2, iv (D1). The above schemes are repeated every three weeks. 2. After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.
DRUG	Anlotinib + Cisplatin + Paclitaxel/ Docetaxel	1. Anlotinib 12mg, po.qd, d1-14; Cisplatin 60-75mg/m2, iv, d1/d1-d3; Paclitaxel 135mg/m2, iv (D1). or Docetaxel 75mg/m2, iv (D1). The above schemes are repeated every three weeks. 2. After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.
DRUG	Anlotinib + Standard first-line chemotherapy	1. Anlotinib 12mg, po.qd, d1-14; Standard first-line chemotherapy determined by the researchers. The above schemes are repeated every three weeks. 2. After 6 cycles, the regimen is changed to Anlotinib (12mg, po.qd, d1-14)+ Capecitabine (500 mg, po. bid, d1-21). The regimen is repeated every 3 weeks until the disease progresses or unacceptable toxicity.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-01
• Completion: 2024-12-01
• First posted: 2022-03-02
• Last updated: 2023-11-28

Locations

7 sites across 1 country: China