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

PHASE2UnknownINTERVENTIONAL
Enrollment

116

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

December 1, 2023

Study Completion Date

December 1, 2024

Conditions
Gastrointestinal Tumors
Interventions
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."

Trial Locations (7)

Unknown

NOT_YET_RECRUITING

Jiangsu Cancer Hospital, Nanjing

NOT_YET_RECRUITING

Jiangsu Province Hospital, Nanjing

NOT_YET_RECRUITING

Affiliated Hospital of Jiannan University, Wuxi

RECRUITING

Wuxi Branch of Rujin Hospital, Wuxi

RECRUITING

Jiading Cental Hospital Shanghai University of Medicine & Health Sciences, Shanghai

RECRUITING

Ruijin Hospital, Shanghai

NOT_YET_RECRUITING

Tongji Hospital of Tongji University, Shanghai

All Listed Sponsors
collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

lead

Ruijin Hospital

OTHER