Clinical trial · Interventional
A Study of Apatinib in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
An Open Single Arm Exploratory Study of Apatinib Mesylate Tablets in Combination With Raltitrexed Treatment in Patients With Advanced Colorectal Cancer
NCT03344614CI-TRIAL-00030387unknownPhase 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)
30 patients with advanced colorectal cancer will be enrolled to observe the efficacy and safety of raltitrexed combined with apatinib as a third-line treatment.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| raltitrexed combined with apatinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- raltitrexed combined with apatinib
- description
- therapeutic regimen : raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles.
- interventionNames
- Drug: raltitrexed combined with apatinib
Primary outcomes (1)
- measure
- PFS
- timeFrame
- 6 months
- description
- Progression-free survival progression-free survival
Secondary outcomes (3)
- measure
- OS
- timeFrame
- 12 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 1.Male or female, ≥ 18 of age; * 2.Histological confirmed advanced colorectal adenocarcinoma,and at least one measurable lesion; * 3.Have failed for ≥ 2 lines of standard chemotherapy(included Fluorouracil, irinotecan and oxaliplatin); * 4.ECOG performance status 0-2; * 5.Life expectancy of more than 3 months; * 6.The main organs function is well, and randomized within 14 days before the relevant inspection indicators to meet the following requirements: 1. blood routine test Hgb ﹥90g/L, ANC﹥1.5×109/L, Platelets ﹥ 100×109/L, 2. biochemical tests Serum Total bilirubin ≤ 1.5 X UNL(upper normal limit), ALT or AST ≤ 2 xUNL, and ﹤ 5 x UNL(Hematogenous metastases), Creatinine clearance rate≥ 60 ml/min(Cockcroft-Gault formula), 3. Doppler echocardiography assessment:LVEF ≥ 50%; * 7.No serious heart, lung, liver, kidney dysfunction; no jaundice and gastrointestinal obstruction; no acute infection; * 8.Signed informed consent; * 9.Good compliance, and family members agree to receive survival follow-up. Exclusion Criteria: * 1.Factors that could have an effect on oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
References
Publications (0)
Data not yet available
No reference posted for this study.