Clinical trial · Interventional
Adjuvant Chemotherapy Combined With Targeted Therapy or Not in the T3-4N2 Colorectal Cancer Patients
Adjuvant Chemotherapy Combined With Targeted Therapy Versus Adjuvant Chemotherapy Alone in the Treatment of Stage T3-4N2 Colorectal Cancer:A Multicenter, Randomized, Phase III Clinical Trail
NCT05797467CI-TRIAL-00066661recruitingPhase 3ClinicalTrials.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 goal of this clinical trial\] is to compare in resectable stage T3-4N2 colorectal cancer. The main question it aims to answer is: whether the use of targeted therapy in combination with adjuvant chemotherapy is associated with improved disease-free survival (DFS) compared to adjuvant chemotherapy alone.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy Effect | — | UNRESOLVED | — |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| FOLFOX chemotherapy regimens | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Combining targeted therapy group
- description
- Adjuvant chemotherapy with targeted therapy
- interventionNames
- Drug: FOLFOX chemotherapy regimens
- Drug: Bevacizumab
- type
- SHAM_COMPARATOR
- label
- Single adjuvant chemotherapy group
- description
- Adjuvant chemotherapy alone
- interventionNames
- Drug: FOLFOX chemotherapy regimens
Primary outcomes (3)
- measure
- 3-year disease-free survival
- timeFrame
- 3 years after operation.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Both sexes, aged 18-75 years; 2. Pathologically confirmed pT3-4N2 stage colorectal adenocarcinoma after surgery; 3. ASA grade \< IV and/or ECOG performance status score ≤ 2 points; 4. Fully understand and voluntarily sign the informed consent form for this study. Exclusion Criteria: 1. A history of other malignant tumors; 2. Patients with severe liver, kidney, cardio-pulmonary, coagulation dysfunction, or underlying diseases that cannot tolerate chemotherapy; 3. Patients allergic to any component in the study; 4. Patients with severe uncontrollable recurrent infections or other severe uncontrollable concurrent diseases; 5. Patients with other factors that may affect the study results or lead to premature termination of the study, such as alcoholism, drug abuse, other serious diseases requiring comprehensive treatment (including mental illness), and severe abnormalities in laboratory tests; 6. Patients with emergent surgery due to intestinal obstruction, intestinal perforation, intestinal bleeding, etc.; 7. Patients with a history of severe mental illness; 8. Pregnant or lactating women; 9. Patients with other clinical or laboratory conditions that the investigators consider inappropriate for participation in this trial.
References
Publications (0)
Data not yet available
No reference posted for this study.