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A open-lable,single arm and exploratory clinical trail of Apatinib for first-line Maintenance treatment of advanced colorectal cancer.

A open-lable,single arm and exploratory clinical trail of Apatinib for first-line Maintenance treatment of advanced colorectal cancer.

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPC-17012668
Enrollment
Unknown
Registered
2017-09-14
Start date
2017-09-18
Completion date
Unknown
Last updated
2017-10-02

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

Conditions

Colorectal cancer

Interventions

Apatinib treatment group:Apatinib Tablets orally

Sponsors

Xinqiao Hospital, Chongqing
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Patients with advanced and / or metastatic colorectal cancer confirmed by pathology; 2. Patients must have at least 1 lesion that is measurable using RECIST v1.1 criteria; 3. Patients receiving first-line chemotherapy and without progression (who are unable to tolerate chemotherapy toxicity can also be treated, but should be evaluated for progression); 4. Aged >18years old, both genders; 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 2; 6. Life expectancy of more than 3 months; 7. Organ functional levels meeting the following criteria: Blood routine: hemoglobin = 80g / L, absolute neutrophil count (ANC) = 1.5×10^9/L, platelet = 90×10^9/L; Blood biochemical: ALT, AST = 2.5 × ULN, if the liver metastasis = 5×ULN, serum total bilirubin = 1.5 × ULN, SCr (serum creatinine) <1.5×ULN, serum albumin = 30g/L; 8. participants volunteered to participate in this study, signed informed consent, compliance, with follow-up.

Exclusion criteria

Exclusion criteria: 1. Patients with high blood pressure and who can not be reduced to normal range by antihypertensive therapy (systolic blood pressure> 140 mmHg, diastolic blood pressure> 90 mmHg), with grade I coronary heart disease, grade I arrhythmia (including QTc prolongation > 470 ms) and grade I cardiac insufficiency; 2. There are several factors that affect oral medicine, such as unable to swallow, uncontrollable nausea and vomitin, or chronic diarrhea and intestinal obstruction; 3. Patients with clear bleeding tendency; 4. Imaging shows that the tumor has violated the important vascular.According to the judgement of investigator,patients in high risk of invasion of vital blood vessels will be caused by fatal bleeding during treatment; 5. Patients with the history of HIV (human immunodeficiency virus) infection; 6. History of abdominal fistula, gastrointestinal perforation or abdominal abscess within 6 month prior to study entry; 7. patients with positive urine protein; 8. Patients with active brain metastasis; 9. Patients with other malignancies within 5 years except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix; 10. Pregnant or lactating women; 11. According to the researcher's judgment, the patients with a serious risk of compromising the patient's safety or affecting the patient's completion of the study can not be allowed to entry the trail; 12. Researchers believe that they are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
PFS;ORR;

Secondary

MeasureTime frame
OS;DCR;

Countries

China

Contacts

Public ContactXiao Weidong

Xinqiao Hospital, Chongqing

Weidong.xiao@126.com+86 13996390860

Outcome results

None listed

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