Gastric CancerPhase 2NCT05095636
Apatinib Monotherapy Versus Apatinib Combined With Camrelizumab for Third-line Treatment of Metastatic Gastric Cancer
A Phase 2 study testing Apatinib Mesylate and Camrelizumab in people with Gastric Cancer and Metastasis, run by Fudan University at 1 site in China.
Trial summary
This open, single-center, randomized phase II study was to evaluate the clinical benefit of apatinib plus camrelizumab which is an anti-Programmed cell death-1 (PD-1) monoclonal antibody, versus apatinib in patients with metastatic gastric cancer refractory to two or more lines of treatment, fully evaluating the… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Metastasis
- What is being tested?
- Apatinib Mesylate and Camrelizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2021to Sep 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
- Age ≥18;
- Locally advanced or recurrent/metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by histopathological examination;
- Standard treatment failure of no less than two lines of systematic treatment (treatment failure is defined as intolerance of toxic and side effects, disease progression during treatment or recurrence after treatment);
- With one or more measurable lesions, the longest diameter measured by spiral CT scan should be at least 10 mm, and the longest diameter measured by conventional CT scan should be at least 20 mm (RECIST standard, version 1.1);
- ECOG score was 0-2;
- Life expectancy ≥12 weeks;
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- The patient has recovered from damage caused by other anti-tumor therapy, received cytotoxic drugs, radiotherapy or surgery for ≥4 weeks, and the wound has completely healed;
- Bone marrow capacity and liver and kidney function were sufficiently reserved 7 days before screening: absolute neutrophil (ANC) count ≥1.5x109 /L; Hemoglobin ≥ 8.0g/ dL; Platelet count ≥80 x109 /L; Total bilirubin < 1.5 times upper normal limit (ULN); ALT and AST< 2.5x ULN (with liver metastasis <5x ULN); Serum creatinine ≤1 x ULN, the clearance rate of endogenous creatinine >50ml/min;
- Women of childbearing age should take effective contraceptive measures;
- Subjects voluntarily joined the study and signed informed consent with good compliance and follow-up.
Who cannot join
- A history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin;
- Patients with hypertension that could not be controlled by antihypertensive medication (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg), coronary heart disease of grade I or above, arrhythmia of grade I or above (including prolonged QTc interval > 450ms in males and > 470 ms in females) and cardiac dysfunction of grade I or above;
- Symptomatic brain or meningeal metastases (unless the patient was treated for >6 months, imaging results were negative within 4 weeks prior to study entry, and tumor-related clinical symptoms were stable at study entry);
- with a history of uncontrolled epileptic seizures, central nervous system dysfunction, or mental disorders;
- Uncontrolled pleural or abdominal effusion;
- Undergoing kidney dialysis;
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- severe or uncontrolled infection;
- pregnant or lactating women who are fertile but have not taken adequate contraceptive measures;
- Multiple factors affecting oral medication (inability to swallow, chronic diarrhea and intestinal obstruction);
- Abnormal coagulation function (PT>16s, APTT>43s, TT>21s, Fbg< 2G /L), bleeding tendency or receiving thrombolytic or anticoagulant treatment;
- patients with gastrointestinal bleeding risk should not be enrolled, including the following conditions :(1) active peptic ulcer lesions and fecal occult blood (++); (2) patients with history of black stools and hematemesis within 3 months;
- Prior exposure to any anti-PD-1 or anti-PD-L1, PD-L2, CD137, CTLA-4 antibody therapy, or any other antibody or drug that specifically targets T-cell costimulation or immune checkpoint pathways.
- Participated in clinical trials of other drugs within four weeks
- Urine routine examination indicated urine protein > 2+
- Received systemic systemic therapy with anti-tumor indications of Chinese herbal medicine or immunomodulatory drugs (including thymosin, interferon, interleukin, etc.) within 2 weeks before the first administration;
- Use of immunosuppressive agents within 4 weeks prior to the first dose of study therapy, excluding nasal, inhaled, or other topical or physiological doses of systemic glucocorticoids (i.e., no more than 10 mg/ d of prednisone or equivalent doses of other glucocorticoids), or hormone use for the prevention of contrast agent allergy.
- Residual liver volume is less than 50% of the total liver volume.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Chenchen Wang, MD, +8613774232040, wccnancy2003@aliyun.com
About this study
Official title: A Phase II Randomized Controlled Trial of Apatinib Monotherapy Versus Apatinib Combined With Camrelizumab in Third-line or Later-line Treatment of Advanced Gastric Adenocarcinoma
This open, single-center, randomized phase II study was to evaluate the clinical benefit of apatinib plus camrelizumab which is an anti-Programmed cell death-1 (PD-1) monoclonal antibody, versus apatinib in patients with metastatic gastric cancer refractory to two or more lines of treatment, fully evaluating the efficacy and safety of the combined regimen.
Read the detailed description
Gastric cancer is one of the most common malignant tumors with the highest mortality in the world. Post-line treatment options for metastatic gastric cancer (mGC) are limited. Monoclonal antibodies targeting Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) and small molecule tyrosine kinase inhibitors (TKIs) have shown benefits on progression free survival (PFS) and overall survival (OS) in second-line or third-line treatment of mGC. Following a phase III randomized clinical trial, apatinib, an oral small-molecule drug targeted with VEGFR-2, has been proved to significantly prolong patients' OS in the third-line or later-line treatment of mGC, thus becoming the standard third-line or later-line regimen for gastric cancer in China. In immunotherapy of mGC, pembrolizumab has been approved for third-line treatment of programmed cell death-Ligand 1 (PD-L1) positive advanced gastric cancer, and nivolumab also become the standard third-line treatment regimen. What is the best option for third-line treatment of metastatic gastric cancer remains unclear. Analysis from the subgroup of the Attraction 2 study showed that patients who had previously been treated with anti-VEGFR targeted drug ramucizumab had significantly higher PFS and OS than those who had not. The REGONIVO study also showed that the anti-angiogenic TKI regorafenib combined with nivolumab achieved a good objective response rate after the failure of standard treatment in gastric cancer. Therefore, it is worth exploring whether apatinib combined with anti-PD-1 monoclonal antibody could bring improvements in PFS and OS while compared with apatinib monotherapy. This open, single-center, randomized phase II study was to evaluate the clinical benefit of apatinib plus camrelizumab which is an anti-PD-1 monoclonal antibody, versus apatinib in patients with metastatic gastric cancer refractory to two or more lines of treatment, fully evaluating the efficacy and safety of the combined regimen. A total of 102 patients were planned for enrollment in this study. This trial was expected to start in March 2021, and the end of recruitment will be approximately on March 2024, and the end of follow-up will be approximately on October 2023. The control group would take apatinib monotherapy regimen, with 500mg oral apatinib every day, and the experimental group would take apatinib plus camrelizumab regimen, with 250 mg oral apatinib every day continuously and 200mg intravenous camrelizumab every 14 days. Patients would be assessed every 8 weeks and those patients with disease control would be received the treatment until progressive disease (PD) or intolerable toxicity. The maximum treatment duration of camrelizumab was 2 years.
- Conditions
- Gastric Cancer, Metastasis
- Being tested
- Apatinib Mesylate, Camrelizumab
- Keywords
- gastric cancer, target therapy, metastasis, apatinib, anti-PD-1 antibody
- Medical subject headings
- Stomach Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Apatinib MesylateDrug
oral Apatinib once everyday
CamrelizumabDrug
intravenous camrelizumab 200mg once every two weeks
| Study group | Role | What they receive |
|---|---|---|
| apatinib monotherapy | Active comparator | Apatinib，500 mg，po., qd, q2w Receives: Drug: Apatinib Mesylate |
| Apatinib Combined With Camrelizumab | Experimental | Apatnib，250 mg，po., qd，q2w; Camrelizumab，200mg， ivgtt，d1, q2w Receives: Drug: Apatinib Mesylate; Drug: Camrelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
progression free survival
Measured: Time Frame: from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
Secondary outcomes (5)
OS
overall survival
Measured: from the time signing of ICF until the date of death from any cause, assessed up to 36 months
DoR
duration of response
Measured: the time between the first tumor evaluation for CR or PR and the first evaluation for PD(Progressive Disease) or death from any cause, assessed up to 36 months
ORR
objective response rate
Measured: the rate of patients with CR and PR, through study completion, an average of 1 year
DCR
disease control rate
Measured: the rate of patients with CR, PR and SD, through study completion, an average of 1 year
AEs
the adverse events of all enrolled patients
Measured: the adverse events rate and types of all enrolled patients, through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start17 Mar 2021
- Primary completionMar 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Fudan 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
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaodong Zhu, Fudan University
- Investigators
- Xiaodong Zhu, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05095636
- Sponsor's protocol ID
- FDZL-CAP
- Status last verified
- Oct 2021
- First submitted
- 2 Oct 2021
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- 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 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Controlled Trial of Apatinib Monotherapy Versus Apatinib Combined With Camrelizumab in Third-line or Later-line Treatment of Advanced Gastric Adenocarcinoma
- ClinicalTrials.gov ID
- NCT05095636
- Acronym / sponsor ID
- FDZL-CAP
- Conditions
- Gastric Cancer, Metastasis
- Keywords
- gastric cancer, target therapy, metastasis, apatinib, anti-PD-1 antibody
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 17 Mar 2021 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 27 Oct 2021 (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 open, single-center, randomized phase II study was to evaluate the clinical benefit of apatinib plus camrelizumab which is an anti-Programmed cell death-1 (PD-1) monoclonal antibody, versus apatinib in patients with metastatic gastric cancer refractory to two or more lines of treatment, fully evaluating the efficacy and safety of the combined regimen.
Detailed description
Gastric cancer is one of the most common malignant tumors with the highest mortality in the world. Post-line treatment options for metastatic gastric cancer (mGC) are limited. Monoclonal antibodies targeting Vascular Endothelial Growth Factor Receptor 2 (VEGFR-2) and small molecule tyrosine kinase inhibitors (TKIs) have shown benefits on progression free survival (PFS) and overall survival (OS) in second-line or third-line treatment of mGC. Following a phase III randomized clinical trial, apatinib, an oral small-molecule drug targeted with VEGFR-2, has been proved to significantly prolong patients' OS in the third-line or later-line treatment of mGC, thus becoming the standard third-line or later-line regimen for gastric cancer in China. In immunotherapy of mGC, pembrolizumab has been approved for third-line treatment of programmed cell death-Ligand 1 (PD-L1) positive advanced gastric cancer, and nivolumab also become the standard third-line treatment regimen. What is the best option for third-line treatment of metastatic gastric cancer remains unclear. Analysis from the subgroup of the Attraction 2 study showed that patients who had previously been treated with anti-VEGFR targeted drug ramucizumab had significantly higher PFS and OS than those who had not. The REGONIVO study also showed that the anti-angiogenic TKI regorafenib combined with nivolumab achieved a good objective response rate after the failure of standard treatment in gastric cancer. Therefore, it is worth exploring whether apatinib combined with anti-PD-1 monoclonal antibody could bring improvements in PFS and OS while compared with apatinib monotherapy. This open, single-center, randomized phase II study was to evaluate the clinical benefit of apatinib plus camrelizumab which is an anti-PD-1 monoclonal antibody, versus apatinib in patients with metastatic gastric cancer refractory to two or more lines of treatment, fully evaluating the efficacy and safety of the combined regimen. A total of 102 patients were planned for enrollment in this study. This trial was expected to start in March 2021, and the end of recruitment will be approximately on March 2024, and the end of follow-up will be approximately on October 2023. The control group would take apatinib monotherapy regimen, with 500mg oral apatinib every day, and the experimental group would take apatinib plus camrelizumab regimen, with 250 mg oral apatinib every day continuously and 200mg intravenous camrelizumab every 14 days. Patients would be assessed every 8 weeks and those patients with disease control would be received the treatment until progressive disease (PD) or intolerable toxicity. The maximum treatment duration of camrelizumab was 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| apatinib monotherapy | Active comparator | Drug: Apatinib MesylateApatinib，500 mg，po., qd, q2w |
| Apatinib Combined With Camrelizumab | Experimental | Drug: Apatinib Mesylate, Drug: CamrelizumabApatnib，250 mg，po., qd，q2w; Camrelizumab，200mg， ivgtt，d1, q2w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥18;
- Locally advanced or recurrent/metastatic gastric or gastroesophageal junction adenocarcinoma confirmed by histopathological examination;
- Standard treatment failure of no less than two lines of systematic treatment (treatment failure is defined as intolerance of toxic and side effects, disease progression during treatment or recurrence after treatment);
- With one or more measurable lesions, the longest diameter measured by spiral CT scan should be at least 10 mm, and the longest diameter measured by conventional CT scan should be at least 20 mm (RECIST standard, version 1.1);
- ECOG score was 0-2;
Key exclusion criteria (17 listed)
- A history of other malignant tumors within 5 years, except cured cervical carcinoma in situ or basal cell carcinoma of the skin;
- Patients with hypertension that could not be controlled by antihypertensive medication (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg), coronary heart disease of grade I or above, arrhythmia of grade I or above (including prolonged QTc interval > 450ms in males and > 470 ms in females) and cardiac dysfunction of grade I or above;
- Symptomatic brain or meningeal metastases (unless the patient was treated for >6 months, imaging results were negative within 4 weeks prior to study entry, and tumor-related clinical symptoms were stable at study entry);
- with a history of uncontrolled epileptic seizures, central nervous system dysfunction, or mental disorders;
- Uncontrolled pleural or abdominal effusion;
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 Mesylateoral Apatinib once everyday | Drug | Apatinib Combined With Camrelizumab, apatinib monotherapy |
| Camrelizumabintravenous camrelizumab 200mg once every two weeks | Drug | Apatinib Combined With Camrelizumab |
Primary outcome
PFS
Time frame: Time Frame: from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months
progression free survival
5 secondary outcomes
OS
Time frame: from the time signing of ICF until the date of death from any cause, assessed up to 36 months
DoR
Time frame: the time between the first tumor evaluation for CR or PR and the first evaluation for PD(Progressive Disease) or death from any cause, assessed up to 36 months
ORR
Time frame: the rate of patients with CR and PR, through study completion, an average of 1 year
DCR
Time frame: the rate of patients with CR, PR and SD, through study completion, an average of 1 year
AEs
Time frame: the adverse events rate and types of all enrolled patients, through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- 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.
Xiaodong Zhu, MD principal investigator
Fudan 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 Apatinib Mesylate and Camrelizumab in people with Gastric Cancer and Metastasis, run by Fudan 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 10 inclusion and 17 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 27 Oct 2021. 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 Chenchen Wang, MD (+8613774232040, wccnancy2003@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: Time Frame: from the time signing of ICF until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 36 months). 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 27 Oct 2021.