Gastric CancerPhase 2NCT04278222
Anlotinib Plus Toripalimab as First-line Treatment for Advanced Gastric Cancer With ECOG 2 (APICAL-GC)
A Phase 2 study testing Anlotinib Plus Toripalimab in people with Gastric Cancer and Immunotherapy, run by Shanghai Changzheng Hospital at 1 site in China.
Trial summary
This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Immunotherapy, Anlotinib
- What is being tested?
- Anlotinib Plus Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2020to 31 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, UICC stage IV gastric cancer;
- no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;
- at least one measurable lesion;
- received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;
- ECOG performance status 2;
- the main organ function to meet the following criteria: HB ≥ 90g / L, ANC ≥ 1.5 × 109 / L, PLT ≥ 80 × 109 / L,BIL <1.5 times the upper limit of normal (ULN), ALT and AST <2.5 × ULN and if liver metastases, BIL < 3 × ULN, ALT and AST <5 × ULN; Serum Cr ≤ 1.5 × ULN;
- Patient's written declaration of consent obtained;
- Estimated life expectancy > 3 months;
Who cannot join
- harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;
- dMMR/MSI-H;
- Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);
- have received anlotinib or other immune checkpoint inhibitor ;
- with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;
- severe wounds or surgery 4 weeks before recruitment;
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- received glucocorticoid (more than 10mg prednisone ) and immunosuppressive agents;
- History of a second malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a dermal basal cell or squamous cell carcinoma or cervical carcinoma in situ, if these were treated curatively.
- pregnancy or breast feeding;
- absent or restricted legal capacity;
- a significant concomitant disease which, in the investigating physician's opinion, rules out the patient's participation in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai
Ke Liu, +86-18502113721, 45352126@qq.com
Yuan-Sheng Zang
About this study
Official title: Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients (ECOG 2) With Advanced Gastric Cancer (APICAL-GC): an Open-label, Single Arm, Phase II Trial
This study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.
Read the detailed description
Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. Toripalimab is a humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. In the present study, we design a single-arm, single center Phase II trial to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line treatment.
- Conditions
- Gastric Cancer, Immunotherapy, Anlotinib, Toripalimab
- Being tested
- Anlotinib Plus Toripalimab
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anlotinib Plus ToripalimabDrug
Anlotinib 12mg oral administration daily d1-d14, q3w; Toripalimab 240mg iv drop d1, q3w
| Study group | Role | What they receive |
|---|---|---|
| Anlotinib Plus Toripalimab | Experimental | the combination of Anlotinib Plus Toripalimab as first-line treatment Receives: Drug: Anlotinib Plus Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
objective response rate
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
Measured: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
Secondary outcomes (5)
Progress Free Survival
Time from treatment beginning until disease progression
Measured: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 8 weeks
Overall Survival
Time from treatment beginning until death from any cause
Measured: From date of treatment beginning until the date of death from any cause, through study completion, an average of 8 weeks
Deepness of response
Investigation of depth of response during first-line treatment
Measured: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
Disease control rate
Proportion of patients with reduction and non-change in tumor burden of a predefined amount, including complete remission, partial remission and stable disease
Measured: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
adverse events
Incidence of Treatment-related adverse Events
Measured: Through study completion, an average of 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start10 Feb 2020
- Primary completion31 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Shanghai Changzheng HospitalThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Changzheng Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuan-Sheng Zang, Shanghai Changzheng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278222
- Sponsor's protocol ID
- APICAL-GC
- Status last verified
- Jul 2024
- First submitted
- 19 Feb 2020
- Last updated
- 10 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
PubMed 35623069
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Anlotinib Plus Toripalimab as First-line Regimen in Frail Patients (ECOG 2) With Advanced Gastric Cancer (APICAL-GC): an Open-label, Single Arm, Phase II Trial
- ClinicalTrials.gov ID
- NCT04278222
- Acronym / sponsor ID
- APICAL-GC
- Conditions
- Gastric Cancer, Immunotherapy, Anlotinib, Toripalimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Changzheng HospitalUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Feb 2020 (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 study is designed to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line regimen.
Detailed description
Anlotinib is a new, orally administered tyrosine kinase inhibitor that targets vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), platelet-derived growth factor receptors (PDGFR), and c-kit. Toripalimab is a humanized immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death 1 (programmed death-1; PD-1), with potential immune checkpoint inhibitory and antineoplastic activities. In the present study, we design a single-arm, single center Phase II trial to evaluate the efficacy and safety of the combination of Anlotinib wiht Toripalimab in advanced gastric cancer with ECOG 2 as first-line treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anlotinib Plus Toripalimab | Experimental | Drug: Anlotinib Plus Toripalimabthe combination of Anlotinib Plus Toripalimab as first-line treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed, UICC stage IV gastric cancer;
- no prior systematic anti-cancer treatment and relapse or metastases was occurred more than 12 months after adjuvant chemotherapy;
- at least one measurable lesion;
- received radiotherapy 3 weeks before recruitment, but the lesion undergoing radiotherapy could not be used to calculate clinical benefit using RECISET criteria;
- ECOG performance status 2;
Key exclusion criteria (11 listed)
- harboring HER2 positive including IHC 3+ or IHC 2+ with Fish positive;
- dMMR/MSI-H;
- Myocardial infarction, unstable angina pectoris, Grade III or IV heart failure (NYHA classification);
- have received anlotinib or other immune checkpoint inhibitor ;
- with known or clinically suspected brain metastases, autoimmune disease, organ transplantation ;
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 |
|---|---|---|
| Anlotinib Plus ToripalimabAnlotinib 12mg oral administration daily d1-d14, q3w; Toripalimab 240mg iv drop d1, q3w | Drug | Anlotinib Plus Toripalimab |
Primary outcome
objective response rate
Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
Proportion of patients with reduction in tumor burden of a predefined amount, including complete remission and partial remission
5 secondary outcomes
Progress Free Survival
Time frame: Evaluation of tumor burden based on RECIST criteria until first documented progress through study completion, an average of 8 weeks
Overall Survival
Time frame: From date of treatment beginning until the date of death from any cause, through study completion, an average of 8 weeks
Deepness of response
Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
Disease control rate
Time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks
adverse events
Time frame: Through study completion, an average of 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Derived from this study: PubMed 35623069Chang X, Ge X, Zhang Y, Xue X. The current management and biomarkers of immunotherapy in advanced gastric cancer. Medicine (Baltimore). 2022 May 27;101(21):e29304. doi: 10.1097/MD.0000000000029304.
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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.
Department of Medical Oncology, Shanghai Changzheng Hospital
Shanghai, China
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 Anlotinib Plus Toripalimab in people with Gastric Cancer and Immunotherapy, run by Shanghai Changzheng Hospital 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 8 inclusion and 11 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 10 Jul 2024. 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?
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?
objective response rate (time frame: Evaluation of tumor burden based on RECIST criteria through study completion, an average of 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278222, which also lists 1 linked publication.
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 10 Jul 2024.