Metastatic Gastric AdenocarcinomaPhase 2NCT05342389
Camrelizumab Combined With Apatinib Versus Apatinib Alone in the Third-line Treatment of Metastatic Gastric Cancer
A Phase 2 study testing Camrelizumab and Apatinib Mesylate in people with Metastatic Gastric Adenocarcinoma and Metastatic Gastroesophageal Junction Adenocarcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
This is a study of Camrelizumab combined with Apatinib versus Apatinib alone in the third-line treatment of metastatic gastric cancer. Paticipants will be radomized to receive treatment of Camrelizumab combined with Apatinib or Apatinib alone. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Metastatic Gastric Adenocarcinoma, Metastatic Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Camrelizumab and Apatinib Mesylate
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2022to 1 Nov 2023
- Phase
- Phase 2
- 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
Who may be able to join
- Male or female patients, age ≥ 18 years;
- Patients with metastatic gastric cancer confirmed by histology or cytology;
- Baseline blood routine and biochemical indicators meet the following criteria:
- 1) Hemoglobin ≥ 9.0 g/dL; 2) Absolute neutrophil count (ANC) ≥ 1,500/mm3; 3) Platelet count≥ 100,000/mm3; 4) Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); 5) Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 ULN; 6) The international standardized ratio of prothrombin time is ≤ 1.5, and part of the thromboplastin time is within the normal range (the lower limit of 1.2 times normal value to the upper limit of 1.2 times normal value); 7) Creatinine ≤ 1.5 ULN; 8) Urine protein <2+ (if urine protein ≥ 2+, then 24h urine protein quantitative protein must be ≤ 1g); 4．The presence of measurable lesions in patients; evaluated by investigators according to the Efficacy Evaluation Criteria (RECIST) v1.1 of Solid Tumors; 5．Eastern Tumor Collaboration Group Behavioral Status Score (ECOG PS) of 0 or 1; 6．Life expectancy ≥ 3 months; 7．The investigator assessed that the patient was able to comply with the protocol requirements; 8．Capable to sign the informed consent document.
Who cannot join
- Patients who have undergone systemic chemotherapy, radiation therapy, surgery, hormone therapy or immunotherapy in the 2 weeks prior to the screening;
- Patients with a history of taking apatinib;
- Patients with hypertension that is difficult to control despite having been treated with multiple antihypertensive drugs (systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 90 mmHg);
- Patients with acute coronary syndrome (including myocardial infarction and unstable angina) within 6 months prior to admission and a history of coronary angioplasty or stenting;
- Patients with large pleural effusions or ascites requiring drainage;
- According to NCI-CTCAE version 5.0, patients with ≥grade 3 active infections;
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- Patients with symptomatic brain metastases;
- Patients with partial or complete gastrointestinal obstruction;
- Patients with interstitial lung disease with symptoms or signs of activity;
- Patients with allergies or hypersensitivity to therapeutic drugs, patients with autoimmune diseases, and have received allogeneic tissue/solid organ transplants;
- Patients requiring systemic corticosteroids (excluding temporary use for trials, prophylactic administration for anaphylactic reactions or to reduce swelling associated with radiotherapy) or immunosuppressants, or patients who had received such therapy less than 14 days prior to admission to this study;
- Patients with seizures who require medication;
- Patients who undergo major surgery (open chest surgery or laparotomy, etc.), laparotomy biopsy, trauma within 28 days before registration. Registration can be carried out on the same day of the week preceding 4 weeks (however, if an artificial anastomosis is performed without bowel resection, it should be within 14 days prior to registration);
- Patients with unhealed wounds, unhealed ulcers or unhealed fractures;
- Patients with a history of allergies to any of the drugs studied, similar drugs or excipients;
- Simultaneous reception of any other anti-tumor therapy, including anti-tumor proprietary Chinese medicines and immunochemicals;
- Pregnant, lactating women, fertile but refusing to use contraception;
- Other situations in which the investigators determined that they were not suitable for inclusion in the study.
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated hosipital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655
Jian Xiao, PhD, 13711114566
About this study
Official title: Prospective, Randomized, Single-center Phase II Clinical Study of Camrelizumab Combined With Apatinib Versus Apaitnib Alone in the Third-line Treatment of Metastatic Gastric Cancer
This is a study of Camrelizumab combined with Apatinib versus Apatinib alone in the third-line treatment of metastatic gastric cancer. Paticipants will be radomized to receive treatment of Camrelizumab combined with Apatinib or Apatinib alone. The primary study hypothesis is that the adding Camrelizumab to Apatinib can prolong the progressive-free survival of the paticipants.
Read the detailed description
Camrelizumab 200mg intravenously 30 - 60 min biweekly; Apatinib mesylate 250mg or 500mg oral daily continuously; The treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurred.
- Being tested
- Camrelizumab, Apatinib Mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CamrelizumabDrug
Also called SHR-1210
a PD-1 antibody
Apatinib MesylateDrug
Also called Ai Tan
an oral tyrosine kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | A fixed dose of Camrelizumab 200mg will be administered intravenously (without preventive medication), and each infusion lasts 45min (no less than 30min, no more than 60min), once every two weeks; During the treatment period, 250 mg of Apatinib mesylate tablets will be taken orally daily continuously, and every 2 weeks is a treatment cycle. The treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurred. Receives: Drug: Camrelizumab; Drug: Apatinib Mesylate |
| Control group | Active comparator | Apatinib mesylate tablets 500 mg will be taken orally daily continuously, every 2 weeks as a treatment cycle. Treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurs. Receives: Drug: Apatinib Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
the interval from randomization to tumor progression or death or the last follow-up
Measured: 1 year
Secondary outcomes (4)
Overall Survival
the interval from randomization to death of any reason or the last follow-up
Measured: 2 years
Objective response rate
the proportion of subjects who achieve a best response of complete response (CR) or partial response (PR) using the RECIST 1.1 criteria
Measured: 2 years
Quality of Life assessed by EORTC QLQ-OG 25
The Europe Organization for Research and Treatment of Cancer,Quality of Life Questionnaire-OG 25 can assess quality of life (HRQL) in patients with tumours of the oesophagus, oesophago-gastric junction and stomach.
Measured: 2 years
Toxicity assessed by CTCAE V5.0
Adverse effects recorded according to CTCAE V5.0
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 May 2022 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Gastric AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Xiao, PhD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05342389
- Sponsor's protocol ID
- MA-II-GC-013
- Status last verified
- Apr 2022
- First submitted
- 16 Apr 2022
- Last updated
- 22 Apr 2022
- 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 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Single-center Phase II Clinical Study of Camrelizumab Combined With Apatinib Versus Apaitnib Alone in the Third-line Treatment of Metastatic Gastric Cancer
- ClinicalTrials.gov ID
- NCT05342389
- Acronym / sponsor ID
- MA-II-GC-013
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 May 2022 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 22 Apr 2022 (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.
This is a study of Camrelizumab combined with Apatinib versus Apatinib alone in the third-line treatment of metastatic gastric cancer. Paticipants will be radomized to receive treatment of Camrelizumab combined with Apatinib or Apatinib alone. The primary study hypothesis is that the adding Camrelizumab to Apatinib can prolong the progressive-free survival of the paticipants.
Detailed description
Camrelizumab 200mg intravenously 30 - 60 min biweekly; Apatinib mesylate 250mg or 500mg oral daily continuously; The treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Camrelizumab, Drug: Apatinib MesylateA fixed dose of Camrelizumab 200mg will be administered intravenously (without preventive medication), and each infusion lasts 45min (no less than 30min, no more than 60min), once every two weeks; During the treatment period, 250 mg of Apatinib mesylate tablets will be taken orally daily continuously, and every 2 weeks is a treatment cycle. The treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurred. |
| Control group | Active comparator | Drug: Apatinib MesylateApatinib mesylate tablets 500 mg will be taken orally daily continuously, every 2 weeks as a treatment cycle. Treatment lasts for up to 2 years or until disease progression, death or intolerable toxicity occurs. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female patients, age ≥ 18 years;
- Patients with metastatic gastric cancer confirmed by histology or cytology;
- Baseline blood routine and biochemical indicators meet the following criteria:
- 1) Hemoglobin ≥ 9.0 g/dL; 2) Absolute neutrophil count (ANC) ≥ 1,500/mm3; 3) Platelet count≥ 100,000/mm3; 4) Total bilirubin ≤ 1.5 times the upper limit of normal value (ULN); 5) Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 ULN; 6) The international standardized ratio of prothrombin time is ≤ 1.5, and part of the thromboplastin time is within the normal range (the lower limit of 1.2 times normal value to the upper limit of 1.2 times normal value); 7) Creatinine ≤ 1.5 ULN; 8) Urine protein <2+ (if urine protein ≥ 2+, then 24h urine protein quantitative protein must be ≤ 1g); 4．The presence of measurable lesions in patients; evaluated by investigators according to the Efficacy Evaluation Criteria (RECIST) v1.1 of Solid Tumors; 5．Eastern Tumor Collaboration Group Behavioral Status Score (ECOG PS) of 0 or 1; 6．Life expectancy ≥ 3 months; 7．The investigator assessed that the patient was able to comply with the protocol requirements; 8．Capable to sign the informed consent document.
Key exclusion criteria (18 listed)
- Patients who have undergone systemic chemotherapy, radiation therapy, surgery, hormone therapy or immunotherapy in the 2 weeks prior to the screening;
- Patients with a history of taking apatinib;
- Patients with hypertension that is difficult to control despite having been treated with multiple antihypertensive drugs (systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 90 mmHg);
- Patients with acute coronary syndrome (including myocardial infarction and unstable angina) within 6 months prior to admission and a history of coronary angioplasty or stenting;
- Patients with large pleural effusions or ascites requiring drainage;
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 |
|---|---|---|
| CamrelizumabAlso: SHR-1210a PD-1 antibody | Drug | Experimental group |
| Apatinib MesylateAlso: Ai Tanan oral tyrosine kinase inhibitor | Drug | Control group, Experimental group |
Primary outcome
Progression-free survival
Time frame: 1 year
the interval from randomization to tumor progression or death or the last follow-up
4 secondary outcomes
Overall Survival
Time frame: 2 years
Objective response rate
Time frame: 2 years
Quality of Life assessed by EORTC QLQ-OG 25
Time frame: 2 years
Toxicity assessed by CTCAE V5.0
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Jian Xiao, PhD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Camrelizumab and Apatinib Mesylate in people with Metastatic Gastric Adenocarcinoma and Metastatic Gastroesophageal Junction Adenocarcinoma, run by Sixth Affiliated Hospital, Sun Yat-sen 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 4 inclusion and 18 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 Apr 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Jian Xiao, PhD (13711114566, xiaoj26@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: 1 year). 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 Apr 2022.