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Raltitrexed + Oxaliplatin (SALOX) plus Bevacizumab as the First Line Treatment in Patients with Advanced Colorectal Cancer: An Open-Label, Multicenter, Prospective Study

Raltitrexed + Oxaliplatin (SALOX) plus Bevacizumab as the First Line Treatment in Patients with Advanced Colorectal Cancer: An Open-Label, Multicenter, Prospective Study

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053431
Enrollment
Unknown
Registered
2021-11-21
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-09-26

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

Conditions

Colorectal cancer

Interventions

Treatment group:Raltitrexed 3 mg/m^2 + Oxaliplatin 130 mg/m^2 + Bevacizumab 7.5 mg/kg

Sponsors

Medical Oncology Fujian Medical University Union Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 75 years, male or female; 2. Histologically or cytologically confirmed colorectal adenocarcinoma; 3. Diagnosed as metastatic colorectal cancer for the first time and cannot undergo radical resection after evaluation, or relapsed more than 12 months after radical operation; 4. At least one measurable lesion (long diameter >= 10 mm or short diameter >= 15 mm for lymph nodes on spiral CT scan as required by RECIST v1.1); 5. Blood routine examination, liver and kidney function meet the following requirements within 7 days before filter: absolute neutrophil count >= 1.5x10^9/L; hemoglobin >= 90 g/L; platelets >= 75x10^9/L; serum total bilirubin = 6 months; 7. ECOG 0 ~ 2; 8. Voluntary informed consent.

Exclusion criteria

Exclusion criteria: 1. Other malignant tumor history, except cured cervical carcinoma in situ and skin basal carcinoma within 5 years; 2. Intestinal obstruction or incomplete intestinal obstruction (need surgical intervention) 3. Any of the following incidences occurred within 6 months before enrollment: cerebrovascular accident (including stroke or transient ischemic attack), myocardial infarction, severe/unstable angina, coronary artery/peripheral artery bypass, congestive heart failure NYHA grade III or IV, arrhythmia requiring medical treatment or clinical significance, prolonged QT interval of electrocardiogram, etc.; 4. Any of the following occurred within 3 months before enrollment: gastric or duodenal ulcer resistant to treatment, erosive esophagitis or gastritis, grade 3 or 4 gastrointestinal oozing/bleeding/hematochezia, gastrointestinal tract perforation/fistula, deep vein thrombosis and pulmonary embolism or other uncontrolled thromboembolic events; 5. Hypersensitivity to study regimen chemotherapy agents; 6. Known central nervous system and brain metastases; 7. According to the judgment of the investigator, those with concomitant diseases that seriously threat the safety of the patient or affect the completion of the study; 8. Pregnant or lactating women 9. Other conditions that investigator think should be excluded.

Design outcomes

Primary

MeasureTime frame
Objective Response Rate;

Secondary

MeasureTime frame
Progress Free Survival;Overall Survival;Disease Control Rate;Quality of Life;Adverse Event;Serious Adverse Event;

Countries

China

Contacts

Public ContactLin Xiaoyan

Fujian Medical University Union Hospital

13950482366@qq.com+86 133659107893

Outcome results

None listed

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