Clinical trial · Interventional
Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
Phase 1 Study of Apatinib and Capecitabine Combination to Maintain Treating Metastatic Colorectal Cancer
NCT03132025CI-TRIAL-00027237unknownPhase 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)
To control apatinib and capecitabine combination to maintain treating metastatic 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 |
|---|---|---|---|
| Metastatic Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| "Apatinib" and "Capecitabine" | Drug | — | UNRESOLVED |
| "Capecitabine" | Drug | Capecitabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A: "apatinib" and "capecitabine"
- description
- Arm A: "apatinib" and "capecitabine" apatinib 250mg qdpo; capecitabine 1000mg/m2 qdpo d1-14 q3w
- interventionNames
- Drug: "Apatinib" and "Capecitabine"
- type
- ACTIVE_COMPARATOR
- label
- B: "capecitabine" single drug
- description
- Arm B: "capecitabine" single drug "capecitabine" 1000mg/m2 qdpo d1-14 q3w
- interventionNames
- Drug: "Capecitabine"
Primary outcomes (1)
- measure
- Progression-free Survival of Patients with Apatinib and Capecitabine Combination That is prolonged
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Informed consent form should be issued prior to conducting any research process; 2. Men or women aged 18-75 years; 3. Patients with advanced and / or metastatic colorectal cancer confirmed by histology or cytology; 4. Patients who has not exposed to apatinib previously and had received oxaliplatin combined with fluorouracil chemotherapy; 5. The estimated survival time is longer than 3 months; 6. ECOG score was 0 or 1; 7. According to the RECIST v1.1 guidance, at least 1 lesion(who had not received radiotherapy) showed that the longest diameter≥10mm(except for lymph node, the short axis of the lymph node must be≥15mm) through CT or MRI(intravenous contrast agent was preferred ) accurate measurement and the lesion should be suitable for repeatable and accurate measurement; the lesion located in the previously irradiated area can be used as a measurable lesion if the lesion was proved in progress; 8. With sufficient organ and bone marrow function, defined as follows: * Hb≥9 g/dL * Absolute neutrophil count ≥1.0 × 109 /L * Platelet count≥75 × 109 /L * Serum bilirubin ≤ 1.5 × ULN, which would not be appropriate for patients with Gilbert syndrome (Persistent or recurrent hyperbilirubinemia, mainly unconjugated bilirubin, with no evidence of hemolysis or abnormal liver pathology) which can consult a doctor * ALT\&AST ≤ 2.5 × ULN; for patients with liver metastases, ALT\&AST ≤ 5 × ULN Calculate the creatinine clearance rate by Cockcroft-Gault formula * Creatinine clearance rate measured( by actual body weight) or by measuring urine collection for 24 hours\> 40 mL/min(the value of the measurement of the 24 - hour urine collection will be used to determine eligibility if the two methods are used) 9. Women of childbearing age must have a pregnancy test (serum or urine) within 7 days before inclusion, the results should be negative and they are willing to use the appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration. Men should agree to use appropriate methods of contraception during the trial and within 6 months of the last experimental drug administration; 10. Patients volunteered to participate in the trial and signed informed consent form with good compliance. Exclusion Criteria: 1. Patients with hypertension and can not be reduced to the normal range with antihypertensive drugs(systolic pressure \>140 mmHg / diastolic pressure \> 90 mmHg),patients with coronary heart disease more than grade II, arrhythmia (including QTc interval Prolongation men\>450 ms, women \>470 ms) and cardiac insufficiency; 2. With a variety of factors affecting oral drugs(such as unable to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction, etc.); 3. Special note: patients with the risk of gastrointestinal bleeding can not be included, including the following: active peptic ulcer lesions and fecal occult blood (+ +); patients with melena and hematemesis in 3 months; for patients with fecal occult blood (+) and primary gastric tumor without surgery should be carried out gastroscopy, patients with ulcero carcinoma of stomach and believed to cause the lesion to bleed by the physician; 4. Abnormal coagulation function(INR\>1.5×ULN、 APTT\>1.5×ULN) with bleeding tendency; 5. With Symptomatic central nervous system metastasis; 6. Pregnant or lactating women; 7. Other patients unsuitable for inclusion considered by the physician.
References
Publications (0)
Data not yet available
No reference posted for this study.