Clinical trial · Interventional
A Study of Bevacizumab Plus XELOX/XELIRI for First-line Treatment in Unresectable Advanced Colorectal Cancer
A Multicenter Phase II Clinical Study of Bevacizumab Combined With Biweekly XELOX/XELIRI Alternative First-line Treatment for Unresectable Advanced Colorectal Cancer
NCT04324476CI-TRIAL-00053569unknownPhase 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 two-weekly alternative regimen of Bevacizumab plus XELOX/XELIRI for First-line Treatment in Unresectable 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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI
- description
- Induction chemotherapy: Alternating Bevacizumab plus XELOX and Bevacizumab plus XELIRI: Bevacizumab: 5mg/kg, iv, 30min, d1, 2w; Oxaliplatin: 85mg/㎡, iv, 120min, d1, 4w; Irinotecan: 150mg/㎡, iv, 90min, d15, 4w; Capecitabine: 1000mg/㎡, bid, d2-8, 2w. Maintenance chemotherapy: Bevacizumab: 7.5mg/kg, iv, 30min, d1, q3w; Capecitabine: 1000mg/㎡, bid, d2-15, 2w.
- interventionNames
- Drug: Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine
Primary outcomes (1)
- measure
- Progression Free Survival 1 (PFS 1)
- timeFrame
- 28 months
Secondary outcomes (4)
- measure
- Progression Free Survival 2 (PFS 2)
- timeFrame
- 28 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18-75 years old; 2. Patients with advanced colorectal adenocarcinoma diagnosed by histopathology, or with metastasis more than 12 months after radical operation, and the metastasis could not be removed; 3. ECOG score ≤ 2, estimated survival time ≥ 3 months; 4. Leucocytes ≥ 3.5 × 109 / L, neutrophils ≥ 1.5 × 109 / L, hemoglobin ≥ 100g / L, platelets ≥ 80 × 109 / L, serum liver enzyme in patients without liver metastasis is not higher than 2.5 times of the upper limit of normal value, serum liver enzyme in patients with liver metastasis is not higher than 5 times of the upper limit of normal value, serum bilirubin level is not higher than 1.5 times of the upper limit of normal value, serum creatinine level is not higher than 1.5 times of the upper limit of normal value; 5. At least one lesion can be measured by CT or MRI; 6. No other history of malignant tumor; 7. Those who are fertile but willing to take contraceptive measures; 8. Sign the written informed consent. Exclusion Criteria: 1. Patients with allergic, hypersensitive constitution and autoimmune diseases; 2. There are only unmeasurable lesions, such as hydrothorax and ascites, carcinomatous lymphangitis, diffuse liver invasion and bone metastasis; No measurable or non assessable lesions; 3. Pregnant or lactated women; 4. Uncontrolled symptomatic brain metastasis or mental disorder can not correctly describe subjective symptoms; 5. Major organ failure; 6. Affecting drug administration, absorption, distribution, metabolism, excretion, etc. the patient has uncontrollable epileptic attack, central nervous system disorder or loss of self-knowledge due to mental disease, physiological or pathological malnutrition, chronic diarrhea, and cachexia; 7. Patients with complete or incomplete ileus; 8. Patients with serious heart disease or history, including documented history of congestive heart failure, high-risk uncontrolled heart rate disorder, angina requiring drug treatment, clinically clear history of heart valve disease, serious myocardial infarction and stubborn hypertension; 9. Severe uncontrollable infection; 10. Alcohol and /or drug abuse or poor compliance of the investigator's judgment.
References
Publications (1)
- DERIVEDLi S, Li X, Xu H, Huang J, Zhu J, Peng Y, Bao J, Zhu L. Alternating modified CAPOX/CAPIRI plus bevacizumab in untreated unresectable metastatic colorectal cancer: a phase 2 trial. Signal Transduct Target Ther. 2024 Dec 11;9(1):346. doi: 10.1038/s41392-024-02048-z. PMID 39658608