Apatinib for the Elderly Advanced Gastric Cancer

Gastric Cancer Clinical Trial

Official title:

A Multicenter, Single-arm, Phase Ⅱ Clinical Trial of Apatinib Monotherapy in Elderly Patients With Advanced Gastric Cancer(GC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104283
• Other study ID #: AHQU-2017001
• Status: Completed
• Phase: Phase 2
• Start date: June 5, 2017
• Est. completion date: June 2, 2020

Study information

• Verified date: March 2022
• Source: Affiliated Hospital of Qinghai University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of our study is to assess the efficacy and safety of apatinib in elderly advanced gastric cancer patients, and to find the relationship between the expression of VEGFR-2 and efficacy of apatinib treatment.

Description:

The trial is funded by Chinese Society of Clinical Oncology-Beijing Xisike Clinical Oncology Research Fundation. The trial is prepared to be registered on the clinicaltrail.gov.

Quality assurance plan: Every participant is enrolled or excluded by two practiced investigators. And two investigators participate in all steps of the trail, including the record of the data, which is compared by the investigators. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the staff of research and financial department of Affliated Hospital of Qinghai University.

Data check: The investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Source data verification: The investigators assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms.

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.

Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators.

Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 47 participants to take part in the trail. The investigators can recruit about 20 participants every year according to previous experiences, so the investigators should recruit about two years.

Plan for missing data: The investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results.

Statistical analysis plan: Statistical analyses would be performed by using SPSS software, version 13.0 (SPSS Inc., IL, USA). Survival analysis would be performed using Kaplan-Meier methodology. Fisher's exact test would be used to analyze the efficacy of treatment. Cox proportional hazards model would be used for multivariate analysis. The level of significance is defined as P < 0.05.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: June 2, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

1. Elderly patients (aged = 60 years) with histologically confirmed advanced adenocarcinoma of the stomach or gastroesophageal junction;

2. Eastern Cooperative Oncology Group (ECOG) performance status 0-1;

3. Progression with or intolerance to one or more lines of chemotherapy;

4. At least one measurable lesion as defined by RECIST 1.1;

5. With acceptable hematologic, cardiac, hepatic, pulmonary and renal function;

6. Can take apatinib orally;

7. Estimated life expectancy = 3 months.

Exclusion Criteria:

1. Patients cannot take apatinib orally for any reason;

2. Patients with uncontrolled central nervous system (CNS) metastases;

3. Patients with massive hydrothorax or ascites;

4. Proteinuria 2+ or 24-hour urinary protein = 1g;

5. Newly-happened traumatism or pathological fracture;

6. Estimated life expectancy ? 3 months;

7. Received chemotherapy in the past 28 days before enrollment;

8. Patients with uncontrolled blood pressure on medication (= 140/90 mmHg);

9. Patients with bleeding tendency, receiving thrombolytics or anticoagulants, receiving intravenous antibiotic treatment, had received bevacizumab or other VEGF TKIs before, or with other primary malignancy (except basal cell skin cancer or cervical carcinoma in situ).

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Apatinib
take apatinib orally until disease progression or appearance of unbearable toxicity

Locations

Country	Name	City	State
China	Affiliated Hospital of Qinghai University	Xining	Qinghai
China	People's Hospital of Qinghai Province	Xining	Qinghai
China	Qinghai Red Cross Hospital	Xining	Qinghai
China	the Fifth People's Hospital of Qinghai Province	Xining	Qinghai
China	Yangquan No.1 People's Hospital	Yangquan	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Affiliated Hospital of Qinghai University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	PFS was defined to be the time from registration to the date of disease progress sion or death resulting from any cause.	1 year
Secondary	Objective response rate (ORR)	ORR was defined as the proportion of eligible patients who achieved a confirmed complete response(CR )or partial response (PR) by RECIST 1.1 criteria evaluated by the investigators.	1 year
Secondary	Disease control rate (DCR)	DCR was defined as the proportion of patients who achieved CR, PR and stable disease (SD) for at least 8 weeks.	1 year
Secondary	Overall survival (OS)	OS was defined to be the time from registration to the date of death resulting from any cause or the last follow-up visit.	1 year