Clinical trial · Interventional
Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
A Phase II Study of Raltitrexed-based Chemotherapy Plus Bevacizumab in Retreated Patients With Advanced Colorectal Cancer
NCT03126071CI-TRIAL-00053582unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The objective is to investigate the efficacy and safety of raltitrexed-based chemotherapy plus bevacizumab in the treatment of advanced colorectal cancer
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Irinotecan | Drug | Irinotecan | ALIAS |
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| Raltitrexed | Drug | Raltitrexed | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Raltitrexed and Irinotecan(RALIRI) plus Bevacizumab(AVASTIN)
- description
- Irinotecan:250mg/m2 iv,90min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)
- interventionNames
- Drug: Raltitrexed
- Drug: Irinotecan
- Drug: Bevacizumab
- type
- EXPERIMENTAL
- label
- Raltitrexed and Oxaliplatin(RALOX) plus Bevacizumab(AVASTIN)
- description
- Oxaliplatin:130mg/m2 iv,120min,d1, Raltitrexed:3.0mg/m2,iv,15min,d1, Bevacizumab:7.5mg/kg iv,30min,d1,q3w. Maintenance: Raltitrexed(3.0mg/m2,iv,15min,d1,q3w)+Bevacizumab(7.5 mg/kg q3w)
- interventionNames
- Drug: Raltitrexed
- Drug: Oxaliplatin
- Drug: Bevacizumab
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 18-70 years; * histological and/or cytological confirmation of ACC; * disease progression while on first-line palliative fluoropyrimidine-based chemotherapy or relapse within 6 months after adjuvant chemotherapy; * at least one measurable objective tumor lesion by spiral CT examination, the maximum diameter ≥ 1cm(according to RECIST 1.1) * ECOG performance status 0-1 * life expectancy of at least 3 months * satisfactory main organ function,laboratory test must meet the following criteria: hemoglobin (HGB) ≥90g/L, neutrophil count(ANC) ≥1.5×109/L, platelet count(PLT) ≥80×109/L, Serum creatinine(CR)≤1.5 upper normal limitation (UNL),total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 UNL (For patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), Alkaline phosphatase(ALP)≤3 UNL(For patients with liver metastasis, the ALP must be ≤5.0 UNL); * written informed consent Exclusion Criteria: * prior exposure to raltitrexed; * Clinically significant cardiovascular disease, for example symptomatic coronary artery disease, myocardial infarction (\<=6 months before treatment start),congestive heart failure (New York Heart Association ,NYHA\>= grade 3),stroke or transient ischemic attack * Accept kidney dialysis treatment now * chronic enteropathy on unresolved bowel obstruction; * previous malignant disease other than carcinoma in situ of the cervix or basal cell carcinoma of the skin; * the UGT1A1 \*28(7/7)\*6(A/A) gene type; * pregnant or lactated women; * Unsuitable for the study or other chemotherapy determined by investigator.
References
Publications (1)
- DERIVEDLi S, Li X, Zhu Q, Gao J, Zhu C, Zhu L. Raltitrexed Chemotherapy Regimen Plus Bevacizumab as Second-Line Treatment for Metastatic Colorectal Cancer: A Prospective Multicenter Phase II Trial. Cancer Control. 2024 Jan-Dec;31:10732748241275012. doi: 10.1177/10732748241275012. PMID 39286935