Clinical Study of Apatinib and 5-Fu Combination Regimen to Treat Advanced Colorectal Cancer Patients

NCT03210064 | Unknown Phase 2 DMC

• 1 other identifier: HXu
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

This study makes an observation over the objective response rate of Apatinib and 5-Fu combination regimen in the three-line treatment of metastatic colorectal cancer. All the participants will randomly receive the treatment of Apatinib and 5-Fu combination regimen or 5-Fu.

Conditions

Metastatic Colorectal Cancer

Keywords

Apatinib

Outcome Measures

Primary Outcomes (1)

• ORR

  The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR)

  From assignment of the first subject to 3 months later after the last participant is recruited.

Secondary Outcomes (4)

• DCR

  From assignment of the first subject to 3 months later after the last participant is recruited.

• PFS

  From assignment of the first subject to 3 months later after the last participant is recruited.

• OS

  From assignment of the first subject until 30 death events observed, up to 2 years.

• QoL

  From assignment of the first subject to 3 months later after the last participant is recruited.

Study Arms (2)

Apatinib and 5-Fluorouracil

EXPERIMENTAL

Apatinib 500 mg qd po.5-Fluorouracil 400mg/m2 iv d1，2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).

Drug: Apatinib; Drug: 5-fluorouracil

5-Fluorouracil

ACTIVE COMPARATOR

5-Fluorouracil 400mg/m2 iv d1，2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).

Drug: 5-fluorouracil

Interventions

Apatinib DRUG

Apatinib Mesylate Tablets 500 mg qd po

Also known as: 5-fluorouracil

Apatinib and 5-Fluorouracil

5-fluorouracil DRUG

5-Fluorouracil 400mg/m2 iv d1，2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).

Also known as: 5-Fluorouracil derivatives

5-Fluorouracil; Apatinib and 5-Fluorouracil

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• and ≤ 70 years of age
• Histological confirmed advanced or metastatic colorectal Cancer，at least one measurable lesion, larger than 10 mm in diameter by spiral CT scan(scanning layer ≤ 5 mm )
• Have failed for ≥ 2 lines of chemotherapy
• Life expectancy of more than 3 months
• ECOG performance scale ≤ 1
• Duration from the last therapy is more than 6 weeks for nitroso or mitomycin More than 4 weeks for operation, radiotherapy or cytotoxic agents
• Adequate hepatic, renal, heart, and hematologic functions (platelets \> 80 × 10E+9/L, neutrophil \> 1.5 × 10E+9/L, serum creatinine ≤ 1×upper limit of normal(ULN), bilirubin \< 1.25 ULN, and serum transaminase ≤ 2.5× ULN)
• Child bearing potential, a negative urine or serum pregnancy test result before initiating apatinib, must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article. Male: All subjects who are not surgically sterile or postmenopausal must agree and commit to the use of a reliable method of birth control for the duration of the study and for 8 weeks after the last dose of test article.
• Signed and dated informed consent. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure.

You may not qualify if:

• History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Pregnant or lactating women
• Preexisting uncontrolled hypertension defined as more than 140/90 mmHg despite using single medical therapy, more than class I (NCI CTCAE 3.0 ) myocardial ischemia, arrhythmia(including QTcF:male ≥ 450 ms, female ≥ 470 ms), or cardiac insufficiency myocardial ischemia, arrhythmia, or cardiac insufficiency
• Before or at the same time any, second malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix
• Any factors that influence the usage of oral administration Evidence of CNS metastasis
• URT: urine protein ≥ (++)and \> 1.0 g of 24 h
• PT, APTT, TT, Fbg abnormal, having hemorrhagic tendency (eg. active peptic ulcer disease) or receiving the therapy of thrombolysis or anticoagulation
• Abuse of drugs
• Certain possibility of gastric or intestine hemorrhage
• Less than 4 weeks from the last clinical trial
• Viral hepatitis type B or type C
• Prior VEGFR inhibitor treatment
• Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study

Sponsors & Collaborators

• Hui ting Xu，MD: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Hui ting Xu

Wuhan, Hubei, 027, China

RECRUITING

Related Publications (1)

• Chen R, Yang L, Hu S, Yin Z, Nie Y, Xu H, Zhong Y, Zhu Y, Liang X, Xu H. Apatinib plus 5-fluorouracil as a third or subsequent-line treatment option for metastatic colorectal cancer: a phase-II, single-arm, prospective study. Ann Transl Med. 2022 Jan;10(2):100. doi: 10.21037/atm-22-77.

  PMID: 35282086 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

apatinib; Fluorouracil

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yan li Nie, MD

  Hu bei CH

  PRINCIPAL INVESTIGATOR

• Liu Yang, MD

  Hu bei CH

  STUDY DIRECTOR

Central Study Contacts

Hui ting XU

CONTACT

15307176219; 2891533@qq.com

Hong li XU

CONTACT

13554458191; xu2010ky@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Deputy Chief Physician

Model Details: Experimental: apatinib combined with 5-Fu

Study Record Dates

• First Submitted: May 15, 2017
• First Posted: July 6, 2017
• Study Start: May 4, 2017
• Primary Completion: April 24, 2018
• Study Completion: April 24, 2019
• Last Updated: July 6, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)