Clinical Study of Apatinib Combined With Second - Line Chemotherapy for Metastatic Colorectal Cancer

NCT03412994 | Unknown Phase 2

• 1 other identifier: ChiCTR1800014478
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

(1) Evaluate the efficacy of apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer. Whether it can prolong Progression Free Survival (PFS), overall survival (OS) in patients with advanced colorectal cancer and reduce symptoms and improve quality of life compared with standard second-line chemotherapy; (2) Observe the safety of apatinib for the treatment of advanced colorectal cancer.

Conditions

Colorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• Progression-free survival (PFS)

  the time from randomize to progression or death; RECIST guidelines were used to define all responses after patients had received every 4 weeks of therapy

  Approximately 2 year

Secondary Outcomes (4)

• Overall survival (OS)

  Approximately 3 years

• Objective Response Rate (ORR)

  Approximately 2 years

• Disease control rate(DCR)

  Approximately 2 years

• Quality of life(QoL)

  Approximately 2 year

Study Arms (2)

Apatinib group

EXPERIMENTAL

Apatinib combined with second-line chemotherapy (5-Fu combined with irinotecan or oxaliplatin standard regimen ) Apatinib tablets: 500 mg po qd . Continuous medication, the cycle is consistent with the chemotherapy cycle. Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.（Take CAPEOX for example）

Drug: Apatinib; Drug: standard second-line chemotherapy

Control group

PLACEBO COMPARATOR

Oxaliplatin: Day 1, 130mg/m2, IV infusion. Capecitabine: Day 1-14, 1000mg/m2 Twice Daily, po. A total of 6 cycles, 3 weeks apart of chemotherapy.（Take CAPEOX for example）

Drug: standard second-line chemotherapy

Interventions

Apatinib DRUG

Apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer

Also known as: YN968D1

Apatinib group

standard second-line chemotherapy DRUG

The second line standard chemotherapy regimen recommended by the NCCN

Also known as: FOLFOX、FOLFIRI、CapeOX

Apatinib group; Control group

Eligibility Criteria

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

You may qualify if:

• Male or female aged 18 to 70 years old;
• Histologically or cytologically proven patients with metastatic colorectal cancer have undergone a first-line standard regimen recommended by the NCCN guidelines for progression;
• According to the RECIST 1.1 criteria, the patient has at least one target lesion that can measure the diameter;
• ECOG PS ≤ 2;
• Expected survival time of more than 12 weeks.
• The level of organ function must meet the following requirements:
• Bone marrow: neutrophil count (ANC) ≥ 1.5 × 10\^9/L, platelet ≥ 75 × 10\^9/L, hemoglobin ≥ 90g/L.
• Liver: serum bilirubin ≤ 2 times the upper limit of normal, aminotransferase AST and ALT ≤ 2.5 times the normal upper limit.
• Kidney: Serum creatinine ≤1.5 times upper limit of normal.
• Patient compliance is good;
• Understand and voluntarily sign a written informed consent.

You may not qualify if:

• Other previous or concurrent malignancy, except cured skin basal cell carcinoma and cervical carcinoma in situ;
• Already known to be allergic to apatinib or any excipient;
• Use unapproved drugs or other test medications within 4 weeks prior to enrollment;
• There are many factors that affect oral medications (such as inability to swallow, chronic diarrhea and intestinal obstruction);
• Patients with a history of CNS metastases or CNS metastases;
• A history of bleeding, with any serious grading within 4 weeks prior to screening reaching a bleeding event of 3 degrees Celsius or greater in CTCAE4.0;
• Serious infection;
• Serious cardiovascular disease: uncontrolled hypertension, unstable angina, grade 3-4 heart failure (NYHA standard), congestive heart failure;
• urinary routine urinary protein ≥ ++ and confirmed 24-hour urinary protein quantitation\> 1.0 g;
• Within 30 days after major surgery;
• Thrombotic disease. Anemia or venous thrombosis occurred in the previous year, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism, etc.;
• Those with history of psychotropic substance abuse who can not be abstinent or have mental disorders;
• Have clinical symptoms, need clinical intervention pleural effusion or ascites;
• At the investigator's discretion, there is a serious concomitant condition that compromises the patient's safety or affects the patient in completing the study.

Sponsors & Collaborators

• Liqiang Zhong: lead

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

apatinib

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

• Liqiang Zhong

  Yibin Second People's Hospital

  STUDY CHAIR

Central Study Contacts

Liqiang Zhong

CONTACT

15283572951; zhongliqiang@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: deputy director of the physicians

Study Record Dates

• First Submitted: January 22, 2018
• First Posted: January 29, 2018
• Study Start: February 28, 2018
• Primary Completion: February 28, 2020
• Study Completion: February 28, 2021
• Last Updated: January 29, 2018

Record last verified: 2018-01