Overview
RALOX or CAPOX + Bevacizumab in the First-line Treatment of Advanced CRC(ROCB Study)
Status:
Recruiting
Recruiting
Trial end date:
2021-12-31
2021-12-31
Target enrollment:
0
0
Participant gender:
All
All
Summary
Raltitrexed is an inhibitor of thymidylate synthase.As a folate antimetabolite drug, raltitrexed has been used in treatment of colorectal cancer(CRC) since 1998, and also used in malignant mesothelioma.Several phase III studies performed in patients with advanced CRC showed that it is as effective as 5-fluorouracil(5-FU) /leucovorin(LV) with regard to response rates and survival. The combination of raltitrexed with oxaliplatin shows response rates of 41%-54% and median survivals of 14.6-14.8 months, which are comparable to those achieved with 5-FU/LV combination with oxaliplatin. This study discussed the efficacy and safety of raltitrexed-oxaliplatin(RALOX) combined with bevacizumab or capecitabine-oxaliplatin(CAPOX) combined with bevacizumab in first-line treatment of patients with advanced colorectal cancer who could not undergo radical surgery. The main endpoint will be progression free survival (PFS). The secondary endpoints will be overall survival, objective response rate and disease control rate (OS,ORR and DCR).It is expected that raltitrexed may be one of options for the treatment of advanced CRC in the first-line setting.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Shenzhen People's HospitalTreatments:
Bevacizumab
Capecitabine
Oxaliplatin
Raltitrexed
Criteria
Inclusion Criteria:- Age 18~75 years;
- Patients are diagnosed by histopathological and/or cytological examination as local
advanced or metastatic colorectal cancer who are unable to undergo radical surgery
with no symptom of the primary lesions;
- There are one or more measurable lesions, the longest diameter of which is at least 10
mm by spiral CT scanning (RECIST standard, version 1.1)
- ECOG performance status (ECOG PS) 0~1;
- Life expectancy not less than 3 month
- Blood routine, liver and kidney function reached the following criteria within 14 days
before screening:
Absolute neutrophil count (> 1.5x109/L); hemoglobin (> 9.0 g/dl); platelet count (> 100
x109/L); total bilirubin (< 1.5 times the normal upper limit (ULN); alanine
aminotransferase and glutamic oxaloacetate aminotransferase (< 2.5 x ULN) in patients with
liver metastasis (< 5 x ULN); alkaline phosphatase (< 3 x ULN( in patients with liver
metastasis < 5 x ULN)); serum creatinine (< 1.5 x ULN);
- Adequate blood 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)). Participants on full-dose anticoagulation must be in a stable phase of
anticoagulant therapy and if taking oral anticoagulation, participants must have an
INR ≤3 without clinically significant active bleeding or a high risk of bleeding.
- Agree to provide histological specimens from previous operations for biomarker
assessment and specimens remain。
- Signed informed consent to be provided
Exclusion Criteria:
- Previous treatment with Raltitrexed;
- With a large amount of pleural effusions or ascites requiring puncture drainage;
- Active clinical severe infections include hepatitis;
- One of the following complications: 1) Gastrointestinal obstruction (including
paralytic ileus) or gastrointestinal bleeding 2) Symptomatic cardiac disease
(including unstable angina, myocardial infarction, and heart failure) 3) Pulmonary
fibrosis or interstitial pneumonia 4) Uncontrolled diabetes mellitus 5) Uncontrolled
diarrhea (that affects daily activities although adequate therapy )
- Symptomatic brain or meningeal metastasis (unless the patient has been treated for > 6
months, the imaging results are negative in the 4 weeks before entering the study, and
the clinical symptoms associated with the tumor are stable at the time of entering the
study);
- Undergoing kidney dialysis;
- History of other malignant tumors within 5 years, except for cured cervical carcinoma
in situ or basal cell carcinoma of the skin;
- Drug abuse and medical, psychological or social conditions may interfere with
patients' participation in the study or have an impact on the evaluation of the study
results;
- Pregnant or lactating females, and males and females reluctant to use contraception
- History of concurrent gastrointestinal perforation or gastrointestinal perforation
within 1 year prior to enrollment
- Pulmonary hemorrhage/hemoptysis ≥ Grade 2 (identified as bright red blood of not less
2.5mL) within 1 month before enrollment.
- History of thoracotomy,laparotomy, or intestinal resection within 28 days prior to
enrollment;
- Unhealed wound (other than suture wounds due to implantation of a central venous
port), traumatic fracture, or gastrointestinal ulcer
- Current cerebrovascular disease or thromboembolism or either within 1 year before
enrollment
- Current anticoagulation therapy or requiring anticoagulation agents (> 325 mg/day of
aspirin)
- Bleeding diathesis, coagulopathy, or coagulation factor abnormality (INR ≥1.5 within
14 days before enrollment)
- Uncontrolled hypertension
- Urine dipstick for proteinuria >+2
- Researchers think those should be excluded