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

NCT03397199 | Unknown Phase 2

• 1 other identifier: AHEAD-HNP052
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  From date of randomization until the date of first documented progression or date of death from any cause

  up to 2 year

Secondary Outcomes (3)

• Objective Response Rate (ORR)

  up to 1 year

• Disease Control Rate (DCR)

  up to 1 year

• Overall survival(OS)

  up to 2 year

Study Arms (1)

Apatinib + S-1

EXPERIMENTAL

Apatinib + S-1

Drug: Apatinib + S-1

Interventions

Apatinib + S-1 DRUG

Apatinib 250mg/d,q.d.,p.o. A course of treatment need 21days. S-1 40-60mg（40mg bid BSA \<1.4, 60mg bid BSA\>1.4），bid,from day1-day 14.

Apatinib + S-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed the informed consent form prior to patient entry.
• Histologically or cytologically diagnosed as metastatic colon or rectal adenocarcinoma patients.
• 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.
• ≥ 18 and ≤ 70 years of age.
• Eastern Cooperative Oncology Group(ECOG) performance status 0 or 1.
• Life expectancy of more than 3 months.
• 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.
• 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.
• 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.

You may not qualify if:

• Uncontrollable hypertension (systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, despite optimal medical therapy).
• Poor glycemic control in diabetes.
• Acute cerebral infarction, or recovery period \<2 months.
• A variety of factors that affect oral absorption (such as inability to swallow, nausea, vomiting, chronic diarrhea, intestinal obstruction, etc.).
• Coagulation dysfunction (INR\> 1.5, PT\> ULN + 4s or APTT\> 1.5 ULN), with bleeding tendency or ongoing thrombolysis or anti-blood coagulation treatment.
• Patients whose routine urine tests indicate that urine protein ≥ ++ or verifies that the 24-h urine protein quantitation ≥ 1.0 g.
• Pregnant or lactating women.
• Cytotoxic drug treatment, radiotherapy within 2 weeks after treatment; had taken two or more oral targeted drugs.
• Other malignant tumors, cutaneous basal cell carcinoma, and cervical cancer in situ in the past 5 years.
• The investigators believe there is any condition that may harm the subject or result in the subject's inability to meet or perform the research requirements
• Severe liver and kidney dysfunction (grade 4) patients should be excluded.
• Any allergy to apatinib should be excluded.
• Persons with a history of substance abuse who can not be abdicated or have mental disorders.
• According to the judgment of the researcher, there is a concomitant disease that seriously endangers the patient's safety or affects the patient in completing the study.
• Patients who underwent surgery within 4 weeks prior to the start of treatment or who had major trauma or fractures. Or there is an unhealed wound before treatment.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

RECRUITING

Related Publications (1)

• Li N, Deng W, Zhang G, Du Y, Guo Y, Ma Y, Wei C, Bie L, Zhang C, Song T, Luo S, Fang B. Low-Dose Apatinib Combined With S-1 in Refractory Metastatic Colorectal Cancer: A Phase 2, Multicenter, Single-Arm, Prospective Study. Front Oncol. 2021 Sep 2;11:728854. doi: 10.3389/fonc.2021.728854. eCollection 2021.

  PMID: 34540697 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

apatinib; S 1 (combination)

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

Study Officials

• Suxia Luo

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Ning Li

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ning Li

CONTACT

13526501903; lining97@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2018
• First Posted: January 11, 2018
• Study Start: January 9, 2018
• Primary Completion: October 1, 2020
• Study Completion: March 1, 2021
• Last Updated: April 15, 2020

Record last verified: 2020-04

Locations

CN (1)