Progression-free Survival;Progression-free Survival;Disease Control Rate; SafetyNCT03531931
Apatinib Combined With Capecitabine Second-line Treatment of Advanced Gastric Cancer: a Single-arm Exploratory Clinical Pilot Trial
An observational study of Progression-free Survival;Progression-free Survival;Disease Control Rate; Safety, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
Trial summary
Gastric cancer is the one of the leading cause of cancer death in the worldwide. Gastric cancer originates from the most superficial mucosal epithelial cells of the stomach wall, which can occur in various parts of the stomach, and can invade different depths and breadth of the gastric wall. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Progression-free Survival;Progression-free Survival;Disease Control Rate; Safety
- What is being tested?
- Apatinib/Capecitatine
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2018to Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with pathologically (included histologically or cytologically) confirmed gastric adenocarcinoma, unresectable local advanced or metastatic tumors; Only second-line gastric cancer patients in late phase and at least one month interval from the latest chemotherapy treatment;
Who may be able to join
- 1. Age：18~75 years; 2. Subjects with pathologically (included histologically or cytologically) confirmed gastric adenocarcinoma, unresectable local advanced or metastatic tumors; 3. Only second-line gastric cancer patients in late phase and at least one month interval from the latest chemotherapy treatment; 4. Previous treatment program without apatinib or capecitabine or any other antiangiogenic medications; 5. Subjects with at least one measurable lesion (defined by RECIST ,version 1.1), which is confirmed by computed tomography (CT) scan or MRI≥10mm .
- 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Survival expectation≥ 3 months; 8. Subjects were recovered from damages caused by other treatments, with the interval ≥ 6 weeks for the treatment of the Nitro or Mitomycin, and 4 weeks for other cytotoxic drugs, radiotherapy or surgery, and the wound is completely healed 9. Subjects without severe heart, lung or liver dysfunction, no jaundice and digestive tract obstruction, and acute infection associated 10. The main organs function normally, and meet the following standards:
- Standard of blood routine examination conforms to ( no blood transfusion within 14 days):
- Hemoglobin (HB)≥ 80 g/L;
- Leukocyte(WBC)≥3.5×109/L;
- Absolute neutrophil count (ANC)≥1.5×109/L;
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- Platelet count (PLT) ≥75×109/L；
- Sufficient liver function:
- Bilirubin(BIL) <1.25×the upper limit of normal (ULN);
- Alanine aminotransferase (ALT), and Aspartate aminotransferase (AST) <2.5×(ULN), Glutamic-pyruvic transaminase(GPT)≤1.5×ULN. If liver metastases occur, ALT and AST <5×(ULN), GPT≤3×(ULT);
- Serum Creatinine(Cr) ≤1.0×（ULN）, or creatinine clearance > 50 mL/min( calculated per the Cockcroft and Gault formula); 11. Females of childbearing potential must receive a pregnancy test within 7 days before participating ( including serum), and the results are negative, and also willingly take appropriate methods for contraception during the trial or within 8 weeks after the latest medication. Males should be surgically sterilized or agreed to use the appropriate contraceptive method during the trial or within 8 weeks after the latest medication.
- 12. Subjects provided written informed consent before participating, willing and able to comply with all aspects of the protocol.
Who cannot join
- 1. Pregnant or lactating females; 2. Subjects previously or meanwhile with other malignancies, except cured cutaneous basal cell carcinoma and cervical carcinoma; 3. Subjects with severe heart, liver, kidney disease; with uncontrolled symptomatic brain metastases; with neurological and psychiatric disorders; with severe infection; 4. With high blood pressure and treated with antihypertensive drugs still unable to reduce to the normal range (systolic pressure > 140 mmhg, diastolic pressure >90 mmhg ); 5. With level I above coronary heart disease, arrhythmia (including QTc period extended, male >450 ms, female >470 ms) and cardiac insufficiency; 6. with obvious gastrointestinal bleeding tendencies, include the following situation: locally active ulcer lesions, fecal occult blood (+ +), and within 2 months with a history of black stool or vomiting of blood; coagulation dysfunction (INR>1.5, APTT>1.5 ULN); 7. With Previous history of cardio-cerebral vascular disease, now still take oral thrombolytic drugs or anticoagulant drugs; 8. Urine protein examination confirmed positive (urine protein detection ++ or above, or 24-hour urine protein quantitative detection >1.0g); 9. According to the investigators' judgment, subjects who put other subjects at risk of the safety or disturb their clinical trial devolpment; 10. There are factors that affect oral administration (such as inability to swallow, persistent uncontrolled nausea, vomiting, chronic diarrhea, and intestinal obstruction); 11. Subjects confirmed unsuitable for the clinical trial by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
First affiliated hospital of xiamen university
Xiamen, Fujian, 0086-361000
Feng Ye, doctor, 13860458889, yefengdoctor@sina.com
About this study
Official title: Single-arm Exploratory Clinical Study on the Second-line Treatment of Advanced Gastric Cancer With Apatinib Mesylate Plus Capecitabine
Gastric cancer is the one of the leading cause of cancer death in the worldwide. Gastric cancer originates from the most superficial mucosal epithelial cells of the stomach wall, which can occur in various parts of the stomach, and can invade different depths and breadth of the gastric wall. Without chemotherapy treatment the GC patients' Median Survival Time (MST) lasts only 3-4 months. Although treated with multi-chemotherapy MST has been improved, the drugs show strong toxicities in the patients. Thus the more accurate, lower toxicity, targeted antitumor drugs are put into second-line treatment program for advanced gastric cancer.
Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to determine whether apatinib plus capecitatine can improve progression free survival in patients with advanced gastric cancer.
- Being tested
- Apatinib/Capecitatine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib/CapecitatineDrug
Apatinib is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2), now being developed by Jiangsu Hengrui Medicine (China). Even at a low concentration apatinib can still perform magnificent VEGFR2 inhibitory activities, meanwhile at little higher concentration it can inhibit PDGFR and kinases as well, such as c-Kit and c-Src .The action sites of apatinib are the intracellular ATP binding site of the protein tyrosine receptor. Pharmacodynamical study shows that apatinib is able to inhibit the tyrosine kinase activity of VEGFR, block signal conduction after the combination of VEGF, finally contribute to stopping new blood vessel formation in tumor tissue.
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
To assess progression-free survival (PFS) in subjects treated with apanitib plus capecitatine as a second-line treatment in whom with advanced gastric cancer or adenocarcinoma of the stomach-esophagus joint.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study startMay 2018 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progression-free Survival;Progression-free Survival;Disease Control Rate; SafetyStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Xiamen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531931
- Sponsor's protocol ID
- 20180509
- Status last verified
- May 2018
- First submitted
- 9 May 2018
- Last updated
- 22 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-arm Exploratory Clinical Study on the Second-line Treatment of Advanced Gastric Cancer With Apatinib Mesylate Plus Capecitabine
- ClinicalTrials.gov ID
- NCT03531931
- Acronym / sponsor ID
- 20180509
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xiamen UniversityUniversity, hospital or other
- Study start
- May 2018 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastric cancer is the one of the leading cause of cancer death in the worldwide. Gastric cancer originates from the most superficial mucosal epithelial cells of the stomach wall, which can occur in various parts of the stomach, and can invade different depths and breadth of the gastric wall. Without chemotherapy treatment the GC patients' Median Survival Time (MST) lasts only 3-4 months. Although treated with multi-chemotherapy MST has been improved, the drugs show strong toxicities in the patients. Thus the more accurate, lower toxicity, targeted antitumor drugs are put into second-line treatment program for advanced gastric cancer.
Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2), shows significant antitumor activity in the patients with GC. The purpose of this study is to determine whether apatinib plus capecitatine can improve progression free survival in patients with advanced gastric cancer.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with pathologically (included histologically or cytologically) confirmed gastric adenocarcinoma, unresectable local advanced or metastatic tumors; Only second-line gastric cancer patients in late phase and at least one month interval from the latest chemotherapy treatment;
Key inclusion criteria (12 listed)
- 1. Age：18~75 years; 2. Subjects with pathologically (included histologically or cytologically) confirmed gastric adenocarcinoma, unresectable local advanced or metastatic tumors; 3. Only second-line gastric cancer patients in late phase and at least one month interval from the latest chemotherapy treatment; 4. Previous treatment program without apatinib or capecitabine or any other antiangiogenic medications; 5. Subjects with at least one measurable lesion (defined by RECIST ,version 1.1), which is confirmed by computed tomography (CT) scan or MRI≥10mm .
- 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 7. Survival expectation≥ 3 months; 8. Subjects were recovered from damages caused by other treatments, with the interval ≥ 6 weeks for the treatment of the Nitro or Mitomycin, and 4 weeks for other cytotoxic drugs, radiotherapy or surgery, and the wound is completely healed 9. Subjects without severe heart, lung or liver dysfunction, no jaundice and digestive tract obstruction, and acute infection associated 10. The main organs function normally, and meet the following standards:
- 12. Subjects provided written informed consent before participating, willing and able to comply with all aspects of the protocol.
Key exclusion criteria (1 listed)
- 1. Pregnant or lactating females; 2. Subjects previously or meanwhile with other malignancies, except cured cutaneous basal cell carcinoma and cervical carcinoma; 3. Subjects with severe heart, liver, kidney disease; with uncontrolled symptomatic brain metastases; with neurological and psychiatric disorders; with severe infection; 4. With high blood pressure and treated with antihypertensive drugs still unable to reduce to the normal range (systolic pressure > 140 mmhg, diastolic pressure >90 mmhg ); 5. With level I above coronary heart disease, arrhythmia (including QTc period extended, male >450 ms, female >470 ms) and cardiac insufficiency; 6. with obvious gastrointestinal bleeding tendencies, include the following situation: locally active ulcer lesions, fecal occult blood (+ +), and within 2 months with a history of black stool or vomiting of blood; coagulation dysfunction (INR>1.5, APTT>1.5 ULN); 7. With Previous history of cardio-cerebral vascular disease, now still take oral thrombolytic drugs or anticoagulant drugs; 8. Urine protein examination confirmed positive (urine protein detection ++ or above, or 24-hour urine protein quantitative detection >1.0g); 9. According to the investigators' judgment, subjects who put other subjects at risk of the safety or disturb their clinical trial devolpment; 10. There are factors that affect oral administration (such as inability to swallow, persistent uncontrolled nausea, vomiting, chronic diarrhea, and intestinal obstruction); 11. Subjects confirmed unsuitable for the clinical trial by investigators.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Apatinib/CapecitatineApatinib is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2), now being developed by Jiangsu Hengrui Medicine (China). Even at a low concentration apatinib can still perform magnificent VEGFR2 inhibitory activities, meanwhile at little higher concentration it can inhibit PDGFR and kinases as well, such as c-Kit and c-Src .The action sites of apatinib are the intracellular ATP binding site of the protein tyrosine receptor. Pharmacodynamical study shows that apatinib is able to inhibit the tyrosine kinase activity of VEGFR, block signal conduction after the combination of VEGF, finally contribute to stopping new blood vessel formation in tumor tissue. | Drug | – |
Primary outcome
progression-free survival
Time frame: 6 month
To assess progression-free survival (PFS) in subjects treated with apanitib plus capecitatine as a second-line treatment in whom with advanced gastric cancer or adenocarcinoma of the stomach-esophagus joint.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Progression-free Survival;Progression-free Survival;Disease Control Rate; Safety, run by The First Affiliated Hospital of Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018.