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Clinical study for apatinib combined with tegafur in the treatment of advanced colorectal cancer and analysis of related prognostic factors

Clinical study for apatinib combined with tegafur in the treatment of advanced colorectal cancer and analysis of related prognostic factors

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800018800
Enrollment
Unknown
Registered
2018-10-10
Start date
2018-11-30
Completion date
Unknown
Last updated
2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced colorectal cancer

Interventions

Case series:Apatinib combined with tegafur

Sponsors

Daping Hospital, Army Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Locally advanced or metastatic colorectal cancer confirmed by pathology; 2. Have at least one evaluable lesion (refer to RECIST 1.1); 3. Patients who progress after second-line standard chemotherapy (patients who cannot tolerate chemotherapy toxicity can also be enrolled). 4. Age 18 years old or above, male or female; 5ECOG PS: 0-2 points; 6. Estimated survival time = 12 weeks; "7. The main organ function levels meet the following criteria: 1) Blood routine examination criteria should be consistent with: ANC=1.5×109/L, PLT=80×109/L, Hb=90g/L (no blood transfusion and blood products within 14 days, no correction by G-CSF and other hematopoietic stimuli) ); 2) Biochemical examination should meet the following criteria: TBIL<1.5×ULN, ALT, AST<2.5×ULN, ALT, AST can be <5×ULN, BUN and Cr=1×ULN or endogenous creatinine clearance = 50ml/min (Cockcroft-Gault formula);7" 8. Women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test (serum or urine) within 7 days prior to enrollment and the results are negative and willing to use appropriate during the trial and 8 weeks after the last administration of the test drug. Method of contraception. 9.Subjects voluntarily participated in this study, signed informed consent, followed up with good compliance.

Exclusion criteria

Exclusion criteria: 1. Patients with hypertension and antihypertensive medication can not be reduced to normal range (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg), with grade I or higher coronary heart disease, grade II arrhythmia (including QTc interval prolongation) >470 ms) and grade II cardiac insufficiency; 2. Have multiple factors affecting oral medications (such as inability to swallow, nausea, vomiting, chronic diarrhea, and intestinal obstruction); 3. Patients with a clear tendency to bleed; 4. Imaging shows that the tumor has invaded important blood vessels or that the patient's tumor has a high probability of invading important blood vessels during treatment and causing fatal bleeding; 5. Have HIV infection or a patient; 6. Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 6 months before enrollment; 7. Patients with positive urine protein; 8. Patients with active brain metastases; 9. Patients with other malignant tumors within 5 years (except for completely cured cervical carcinoma in situ or basal cells or squamous epithelial skin cancer); 10. Pregnant or lactating women; those who have fertility are unwilling or unable to take effective contraceptive measures; 11. According to the investigator's judgment, there are serious patients who are at risk to the patient's safety or affect the patient's accompanying disease to complete the study; 12. The investigator believes that it is not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
progression-free survival;

Secondary

MeasureTime frame
Overall survival;Disease control rate;Objective remission rate;Quality of Life;

Countries

China

Contacts

Public ContactGe Wang

Daping Hospital, Army Medical University

742676160@qq.com+86 13023309167

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026