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Tahapan Penelitian : Awal
Sponsor:
Mitra Pelaksana:
RSK Dharmais
No Registry
INA-N2ZX642
Tanggal Input Registry : 29-03-2022

13-04-2022
- Response rate
- OS (Overall Survival) - PFS (Progression - Free Survival) - TTP (Time to Progression) - DOR (Duration of Response)
 
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Bevacizumab compared to AVASTIN in Combination with Capecitabine Plus Oxaliplatin (CAPEOX) as First-Line Therapy in Metastatic Colorectal Cancer: A Preliminary Open-Label Study
Eksperimental
Treatment Arm 1 Bevagen/Bevacizumab(Once each cycle for 6 cycles)+ Oxaliplatin (Once each cycle for 6 cycles) + Capecitabine (q.d. 14 days each cycle for 6 cycles) Treatment Arm 2 Avastin (Once each cycle for 6 cycles) + Oxaliplatin(Once each cycle for 6 cycles) + Capecitabine (q.d. 14 days each cycle for 6 cycles)
45
 

Inclusion Criteria:

- Age ≥ 18 years - Histologically confirmed mCRC-Biopsy Histology - ≥ 1 unidimensionally measurable lesions-can be seen by CT-scan - ECOG performance status of < 1 - A life expectancy of > 3 months - No prior systemic therapy for mCRC or - No previous treatment with oxaliplatin or bevacizumab or capecitabine - Radiotherapy or surgery for mCRC that completed ≥ 4 weeks before randomization. - Have adequate hematologic/clotting, hepatic, renal function (renal and liver functioning normally)

Exclusion Criteria:

- Pregnant or breast-feeding women - Clinically Significant Cardiovascular disease - Clinically detectable ascites - Use of full-dose anticoagulants or thrombolytics - Known Central Nervous Systems metastases - Serious non-healing wound, ulcer, or bone fracture - Clinically significant bleeding diathesis or coagulopathy - Proteinuria ≥ 500 mg/24 hours - Current or history of participation in other clinical trial within 3 months before randomization - Not able to take drug orally - Confirmed positive COVID-19
 
097/KEPK/X/2021
N/A
RG.01.06.1.3.01.22.07
Version 03
Yustina Ari, Priyanka Wisman