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Safety and Efficacy Study of FOLFOX Plus Apatinib as Second-line Therapy in Metastatic Colorectal Cancer

Safety and Efficacy Study of FOLFOX Plus Apatinib as Second-line Therapy in Metastatic Colorectal Cancer

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OIC-17011734
Enrollment
Unknown
Registered
2017-06-21
Start date
2017-08-01
Completion date
Unknown
Last updated
2017-07-03

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

Conditions

colorectal cancer

Interventions

Experimental group:FOLFOX plus apatib

Sponsors

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Histologically-confirmed inoperable colorectal adenocarcinoma; 2. Aged =18 years; 3. ECOG 0-1; 4. Life expectancy of at least 90 days; 5. Withdrawal from first-line chemotherapy (regardless of containing molecular-targeted drugs) for metastatic colorectal cancer due to intolerable toxicity or progressive disease, or relapse within 180 days after the last dose of adjuvant chemotherapy; 6. Adequate organ function according to following laboratory values obtained within 14 days before enrolment (excluding patients who received blood transfusions or hematopoietic growth factors within 14 days before the laboratory test) Neutrophil count: =1500/mm3 Platelet count: =10.0 x 104/mm3 Hemoglobin: =9.0 g/dL Total bilirubin: =1.5 mg/dL AST, ALT: =100 IU/L (=200 IU/I if liver metastases present) Serum creatinine: =1.5 mg/dL; 7. Measurable or nonmeasurable disease based on the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); 8. Adequate coagulation function [International Normalized Ratio (INR) =1.5 and Partial Thromboplastin Time (PTT) or activated PTT (aPTT) =1.5 x upper limit of normal (ULN)) and no clinically significant active bleeding.

Exclusion criteria

Exclusion criteria: 1. History of other malignancy with a disease-free interval +2.

Design outcomes

Primary

MeasureTime frame
PFS;

Secondary

MeasureTime frame
OS;ORR;DCR;QoL;

Countries

China

Contacts

Public ContactTao Zhang

Cancer Center, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

taozhangwh@aliyun.com+86 18971656660

Outcome results

None listed

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