Clinical trial · Interventional
An Exploratory Study of Sequential Transarterial Chemoembolization With Lipiodol and Neoadjuvant Chemotherapy in the Treatment of Initial Unresectable Colorectal Cancer (CRC)
An Exploratory Study of Sequential Transarterial Chemoembolization With Lipiodol and Neoadjuvant Chemotherapy in the Treatment of Initial Unresectable Colorectal Cancer
NCT05340231CI-TRIAL-00057990unknownPhase 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)
This is a prospective, open-labelled study to evaluate the efficacy and safety of sequetial transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy in the treatment of initial unresectable colorectal cancer. The progression-free-survival (PFS) will be evaluated as the primary endpoints.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Neoadjuvant Chemotherapy | Drug | — | UNRESOLVED |
| TACE protocol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Study group
- description
- sequential transarterial chemoembolization with lipiodol and neoadjuvant chemotherapy
- interventionNames
- Drug: TACE protocol
- type
- ACTIVE_COMPARATOR
- label
- Control group
- description
- neoadjuvant chemotherapy alone
- interventionNames
- Drug: Neoadjuvant Chemotherapy
Primary outcomes (1)
- measure
- PFS
- timeFrame
- up to 3 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Has fully understood and voluntarily signed an written Informed Consent and agreed to follow the research plan treatment and visiting plan; 2. Aged \>=18 years, \<= 85 years; 3. Histologically confirmed initial unresectable colorectal cancer; 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 5. Expected survival period ≥ 3 months; 6. At least one measurable lesion, according to RECIST 1.1; 7. The main function is normal. Exclusion Criteria: 1. Known hypersensitivity to any of the study drugs or excipients; 2. Hypertension that is not controlled by the drug; 3. International normalized ratio (INR) \> 1.5 or partially activated prothrombin time (APTT) \> 1.5 × ULN; 4. WBC count \< 3000 /mm\^3; 5. Platlet count \< 50000 /mm\^3; 6. Poorly controlled diabetes before enrollment; 7. Clinically significant electrolyte abnormalities judged by researchers; 8. Patients with obvious evidence of bleeding tendency or medical history of hematochezia within 3 months before enrollment; 9. Cardiovascular diseases with significant clinical significance, including but not limited to acute myocardial infarction, severe / unstable angina pectoris or coronary artery bypass grafting within 6 months before enrollment; Congestive heart failure, New York Heart Association (NYHA) grade \> 2; ventricular arrhythmia requiring drug treatment; LVEF (left ventricular ejection fraction) \< 50%; 10. Active infection or serious infection that is not controlled by drug; 11. History of clinically significant hepatic disease (ALT and/or AST \>5 times the upper normal limit); 12. Women who are pregnant or lactating; 13. Urinary protein ≥ ++, and the 24-hour urine protein quantification is greater than 1.0g; 14. Have any other disease, metabolic disorder, physical examination anomaly, abnormal laboratory result, or any other conditions, which according to the judgment of the investigator, it is reasonable to suspect that the patient is not suitable for the use of the study drug.
References
Publications (0)
Data not yet available
No reference posted for this study.