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UNKNOWNPHASE2

Study of Apatinib Plus S-1 as the Therapy of Advanced Colorectal Cancer

A Phase II Clinical Trial of Apatinib Plus S-1 as the Therapy of Advanced Colorectal Cancer

NCT03397199•Henan Cancer Hospital

Summary

The purpose of this study is to confirm the safety and efficacy of Apatinib plus S-1 as the Therapy of Advanced Colorectal Cancer.

Detailed Description

Colorectal cancer is a common clinical gastrointestinal cancer. In addition to the early diagnosis of some patients, approximately 50% of patients have had distant metastases at the time of diagnosis. For patients with advanced colorectal cancer, systemic chemotherapy is the main treatment. We consider to add apatinib,a tyrosine kinase inhibitor of VEGF,to the therapy of these patients. We designed the study to explore the possibility of apatinib for Advanced Colorectal Cancer.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Signed the informed consent form prior to patient entry.
•2. Histologically or cytologically diagnosed as metastatic colon or rectal adenocarcinoma patients.
•3. The second-line standard regimen failed (disease progression) and the chemotherapy regimen included fluorouracil (5-FU / capecitabine / tioguanide), oxaliplatin and irinotecan from the last chemotherapy\> 14 days.
•4. ≥ 18 and ≤ 70 years of age.
•5. Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
•6. Life expectancy of more than 3 months.
•7. According to the solid tumor efficacy evaluation criteria RECISTv1.1 standards, at least one measurable lesions. If the previous treatment of local treatment (radiotherapy, radiofrequency, intervention, etc.) is the only focus of lesions, the request must have a clear imaging progress.
•8. Adequate hepatic, renal, heart, and hematologic functions: ANC ≥1.5×109/L, PLT ≥ 100×109/L, HB ≥ 90 g/L, TBIL ≤ 1.5×ULN, ALT or AST≤ 2.5×ULN (or ≤ 5×ULN in patients with liver metastases), Serum Cr≤ 1.5×ULN, Cr clearance ≥ 60 mL/min.
•9. Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 6 months after discontinuing study drug. Male subjects must agree to use contraceptive measures during the study and 6 months after last dose of study drug.

Exclusion Criteria

•1. Uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy).
•2. Poor glycemic control in diabetes.
•3. Acute cerebral infarction, or recovery period \<2 months.
•4. A variety of factors that affect oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
•5. Patients with gastrointestinal bleeding risk may not be included, including the following: (1) active peptic ulcer lesions and fecal occult blood (++); (2) history of melena and vomiting within 3 months；Fecal occult blood (+) is not an exclusion criterion.
•6. Coagulation dysfunction (INR\> 1.5, PT\> ULN + 4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
•7. Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g.
•8. Pregnant or lactating women.
•9. Cytotoxic drug treatment, radiotherapy within 2 weeks after treatment; had taken two or more oral targeted drugs.
•10. Other malignant tumors, cutaneous basal cell carcinoma, and cervical cancer in situ in the past 5 years.
+12 more criteria

Locations (1)

Henan Cancer Hospital

Zhengzhou, Henan, China

Key Dates

Start Date

January 9, 2018

Primary Completion Date

October 1, 2020

Completion Date

March 1, 2021

Last Updated

April 15, 2020

Enrollment

120

ESTIMATED participants

Conditions

Colorectal Cancer

Interventions

Apatinib + S-1

DRUG

Contacts

Ning Li

CONTACT

13526501903 lining97@126.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Apatinib Plus S-1 as the Therapy of Advanced Colorectal Cancer

Inclusion Criteria

Exclusion Criteria

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