Gastric CancerPhase 2NCT04609176
Study of Camrelizumab (SHR-1210) and Apatinb Based Therapies for Alpha-fetoprotein (AFP)-Producing Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
A Phase 2 study testing Camrelizumab plus Apatinib and SOX and Camrelizumab plus Apatinib in people with Gastric Cancer, run by Peking University at 1 site in China.
Trial summary
This is a study of Camrelizumab (SHR-1210) and Apatinb for unresectable Recurrent or metastatic alpha-fetoprotein (AFP)-producing gastric cancer or Gastroesophageal Junction Adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Camrelizumab plus Apatinib and SOX and Camrelizumab plus Apatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteChina
- Study dates
- 18 Nov 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
- Patients who provided written informed consent to be subjects in this trial
- Aged ≥18 years
- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Has histologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
- Clinical staging was performed according to enhanced CT/MRI examination (combined with endoscopic ultrasonography and diagnostic laparoscopic exploration if necessary). For patients with locally advanced or metastatic gastric/GEJ cancer in stage III-IV (AJCC 8 edition TNM stage) that could not be resected, the possibility of resectable was determined by MDT
- For cohort 1, no prior systemic chemotherapy for the treatment of the participant's advanced or metastatic disease (treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as completed at least 6 months prior to the diagnosis of advanced or metastatic disease); for cohort 2, received and progressed on ≥1 prior systemic therapy for their advanced disease.
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- Have measurable disease as defined by RECIST 1.1 as determined by investigator assessment
- Serum AFP > 2 upper limit of normal (ULN) or AFP positive by immunohistochemical staining methods
- Adequate Organ Function Laboratory Values:
- Hemoglobin ≥90g/L; Absolute neutrophil count (ANC) ≥1.5×109/L; Platelets ≥80×109/L; AST and ALT ≤ 2.5 ULN or ≤ 5 ULN for subjects with liver metastases; Total bilirubin ≤1.5 ULN; Serum creatinine ≤1.5 ULN or measured or calculated creatinine clearance > 50ml/min; Albumin ≥ 30g/L;
- No serious concomitant disease result in survival of less than 5 years
- Patients capable of taking oral medication
- Have good compliance and be able to follow the study protocol
- Female subjects of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study medication and must be willing to use an adequate method of contraception for the course of the study through 90 days after the last dose of study medication. Male subjects of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 90 days after the last dose of study therapy
- Agree to provide blood and/or tumor tissue sample deemed adequate for PD-L1 and other biomarker analysis.
Who cannot join
- Is pregnant or breastfeeding
- HER2 positive subjects will be excluded from cohort 1
- Patients have recovered adverse events associated with pretreatment to Grade 1 or lower with CTCAE v5.0 excluding alopecia
- Patients have an active malignancy (except for definitively treated basal cell carcinoma of the skin, or carcinoma-in-situ of the cervix) within the past 5 years
- Active heart disease that is not well controlled, e.g. symptomatic coronary heart disease, New York Heart Association (NYHA) congestive heart failure of grade II or above, severe arrhythmias requiring drug intervention, myocardial infarction within the past 12 months, QTc ≥ 450ms for male, QTc ≥ 450ms for female, LVEF<50%
- Genetic or acquired bleeding and thrombotic tendencies (e.g., hemophilia, coagulation disorders, thrombocytopenia, etc.)
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- Patients with a history of gastrointestinal perforation, intra-abdominal abscess, or in-three-months ileus
- Coagulation disorders (International normalized ratio, INR > 2.0 or Prothrombin time, PT > 16s)
- Organ transplantation requires immunosuppressants, or who have received immunosuppressants/systemic corticosteroids therapy <14 days before first dose for an immunosuppression purpose (> 10mg/day prednisone or other equivalency drugs)
- Patients have an active ulcer, serious non-healing wound, or bone fracture
- Patients with hypertension that is difficult to control (systolic blood pressure ≥140 mmHg and diastolic blood pressure ≥90 mmHg) despite treatment with several hypotensive agents
- Patients have a deficiency of dihydropyrimidine dehydrogenase (DPD) will be excluded from cohort 1
- Have any contraindications for study treatment
- Patients with a history of prior treatment with Apatinib or any anti-PD-1, anti-PD-L1 agent
- Urinary protein is more than 2+ and 24-hour urine protein > 1.0g
- Patients with active hepatitis B (HBsAg positive and HBV DNA≥500 IU/ml), hepatitis C (HCV antibodies positive and HCV RNA copies > ULN); with active infection requiring drug intervention
- Patients with active symptoms or signs of interstitial lung disease
- Patients with concurrent autoimmune disease, or a history of chronic or recurrent autoimmune disease
- Patients were judged unsuitable as subjects of this trial by investigators.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Cancer Hospital
Beijing
Xiaotian Zhang, 86-10-88196175, zhangxiaotianmed@163.com
About this study
Official title: A Prospective, Non-randomized, Multicenter, Phase II Study of Camrelizumab (SHR-1210) and Apatinb Based Therapies for Unresectable Recurrent or Metastatic Alpha-fetoprotein (AFP)-Producing Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
This is a study of Camrelizumab (SHR-1210) and Apatinb for unresectable Recurrent or metastatic alpha-fetoprotein (AFP)-producing gastric cancer or Gastroesophageal Junction Adenocarcinoma. Camrelizumab combined with Apatinib and standard chemotherapy will be given to treatment-naïve participants; Camrelizumab combined with Apatinib will also be evaluated in participants who have had ≥ 1 line of previous treatment. The primary endpoint is the Overall Response Rate (ORR).
Read the detailed description
This study will have 2 cohorts. In Cohort 1, participants who have not received any previous therapy for their disease will receive Camrelizumab and Apatinib in combination with Oxaliplatin and S-1. In Cohort 2, participants who have received at least one prior therapy for their advanced disease will receive Camrelizumab and Apatinib. A Simon two-stage phase II design was used for the sample size Calculation.
- Conditions
- Gastric Cancer
- Being tested
- Camrelizumab plus Apatinib and SOX, Camrelizumab plus Apatinib
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab plus Apatinib and SOXDrug
Camrelizumab 200mg, day1; Apatinib 250mg qd p.o.;Oxaliplatin 130 mg/m2 day1; S-1 40-60 mg (calculated according to the body surface area) bid day1-14. 3 weeks for one cycle.
Camrelizumab plus ApatinibDrug
Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle.
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab+Apatinib+SOX | Experimental | Participants who have not received any previous therapy for their disease will receive Camrelizumab and Apatinib in combination with Oxaliplatin and S-1. Camrelizumab 200mg, day1; Apatinib 250mg qd p.o.;Oxaliplatin 130 mg/m2 day1; S-1 40-60 mg (calculated according to the body surface area) bid day1-14. 3 weeks for one cycle. Receives: Drug: Camrelizumab plus Apatinib and SOX |
| Camrelizumab+Apatinib | Experimental | Participants who have received at least one prior therapy for their advanced disease will receive Camrelizumab and Apatinib. Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle. Receives: Drug: Camrelizumab plus Apatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.
Measured: Up to approximately 24 months
Secondary outcomes (9)
Objective Response Rate (ORR) According to iRECIST 1.1 based on investigator assessment
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to iRECIST 1.1 based on investigator assessment.
Measured: Up to approximately 24 months
Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment
DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to RECIST 1.1 based on investigator assessment.
Measured: Up to approximately 24 months
Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment
DOR was defined as the time from first documented evidence of CR or PR until disease progression (according to RECIST 1.1 )or death due to any cause, whichever occurs first.
Measured: Up to approximately 24 months
Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment
PFS was defined as the time from randomization to the first documented disease progression per RECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.
Measured: Up to approximately 24 months
Disease Control Rate (DCR) According to iRECIST 1.1 base on investigator assessment
DCR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR or SD according to iRECIST 1.1 based on investigator assessment.
Measured: Up to approximately 24 months
Duration of Response (DOR) According to iRECIST 1.1 base on investigator assessment
DOR was defined as the time from first documented evidence of CR or PR until disease progression (according to iRECIST 1.1) or death due to any cause, whichever occurs first.
Measured: Up to approximately 24 months
Progression-free Survival (PFS) According to iRECIST 1.1 base on investigator assessment
PFS was defined as the time from randomization to the first documented disease progression per iRECIST 1.1 based on investigator assessment, or death due to any cause, whichever occurs first.
Measured: Up to approximately 24 months
Overall Survival (OS)
OS was defined as the time from randomization to death due to any cause.
Measured: Up to approximately 24 months
Number of Participants Experiencing an Adverse Event (AE)
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the Sponsor's product was also an adverse event. The number of participants who experienced an AE was reported for each arm according to the treatment received. The grade of AE will be assessed per CTCAE 5.0.
Measured: Up to approximately 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start18 Nov 2020
- Primary completion31 Dec 2023 (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 Peking 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Responsible party
- Principal investigator, Shen Lin, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609176
- Sponsor's protocol ID
- MA-GC-II-007
- Status last verified
- Apr 2023
- First submitted
- 17 Oct 2020
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wang Y, Lu J, Chong X, Wang C, Chen X, Peng Z, Gu Y, Wang Y, Wang X, Li J, Gong J, Qi C, Yuan J, Lu Z, Lu M, Zhou J, Cao Y, Chen Y, Zhang C, Hou Z, Kou H, Shen L, Zhang X. PD-1 antibody camrelizumab plus apatinib and SOX as first-line treatment in patients with AFP-producing gastric or gastro-esophageal junction adenocarcinoma (CAP 06): a multi-center, single-arm, phase 2 trial. Signal Transduct Target Ther. 2025 Mar 14;10(1):100. doi: 10.1038/s41392-025-02193-z.
PubMed 40082418
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-randomized, Multicenter, Phase II Study of Camrelizumab (SHR-1210) and Apatinb Based Therapies for Unresectable Recurrent or Metastatic Alpha-fetoprotein (AFP)-Producing Gastric Cancer or Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT04609176
- Acronym / sponsor ID
- MA-GC-II-007
- Conditions
- Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
- Study start
- 18 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 30 Oct 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 is a study of Camrelizumab (SHR-1210) and Apatinb for unresectable Recurrent or metastatic alpha-fetoprotein (AFP)-producing gastric cancer or Gastroesophageal Junction Adenocarcinoma. Camrelizumab combined with Apatinib and standard chemotherapy will be given to treatment-naïve participants; Camrelizumab combined with Apatinib will also be evaluated in participants who have had ≥ 1 line of previous treatment. The primary endpoint is the Overall Response Rate (ORR).
Detailed description
This study will have 2 cohorts. In Cohort 1, participants who have not received any previous therapy for their disease will receive Camrelizumab and Apatinib in combination with Oxaliplatin and S-1. In Cohort 2, participants who have received at least one prior therapy for their advanced disease will receive Camrelizumab and Apatinib. A Simon two-stage phase II design was used for the sample size Calculation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab+Apatinib+SOX | Experimental | Drug: Camrelizumab plus Apatinib and SOXParticipants who have not received any previous therapy for their disease will receive Camrelizumab and Apatinib in combination with Oxaliplatin and S-1. Camrelizumab 200mg, day1; Apatinib 250mg qd p.o.;Oxaliplatin 130 mg/m2 day1; S-1 40-60 mg (calculated according to the body surface area) bid day1-14. 3 weeks for one cycle. |
| Camrelizumab+Apatinib | Experimental | Drug: Camrelizumab plus ApatinibParticipants who have received at least one prior therapy for their advanced disease will receive Camrelizumab and Apatinib. Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Patients who provided written informed consent to be subjects in this trial
- Aged ≥18 years
- Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale
- Has histologically-confirmed diagnosis of locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma
- Clinical staging was performed according to enhanced CT/MRI examination (combined with endoscopic ultrasonography and diagnostic laparoscopic exploration if necessary). For patients with locally advanced or metastatic gastric/GEJ cancer in stage III-IV (AJCC 8 edition TNM stage) that could not be resected, the possibility of resectable was determined by MDT
Key exclusion criteria (19 listed)
- Is pregnant or breastfeeding
- HER2 positive subjects will be excluded from cohort 1
- Patients have recovered adverse events associated with pretreatment to Grade 1 or lower with CTCAE v5.0 excluding alopecia
- Patients have an active malignancy (except for definitively treated basal cell carcinoma of the skin, or carcinoma-in-situ of the cervix) within the past 5 years
- Active heart disease that is not well controlled, e.g. symptomatic coronary heart disease, New York Heart Association (NYHA) congestive heart failure of grade II or above, severe arrhythmias requiring drug intervention, myocardial infarction within the past 12 months, QTc ≥ 450ms for male, QTc ≥ 450ms for female, LVEF<50%
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 |
|---|---|---|
| Camrelizumab plus Apatinib and SOXCamrelizumab 200mg, day1; Apatinib 250mg qd p.o.;Oxaliplatin 130 mg/m2 day1; S-1 40-60 mg (calculated according to the body surface area) bid day1-14. 3 weeks for one cycle. | Drug | Camrelizumab+Apatinib+SOX |
| Camrelizumab plus ApatinibCamrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle. | Drug | Camrelizumab+Apatinib |
Primary outcome
Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment
Time frame: Up to approximately 24 months
ORR was defined as the percentage of the participants in the analysis population who had a confirmed CR or PR according to RECIST 1.1 based on investigator assessment.
9 secondary outcomes
Objective Response Rate (ORR) According to iRECIST 1.1 based on investigator assessment
Time frame: Up to approximately 24 months
Disease Control Rate (DCR) According to RECIST 1.1 based on investigator assessment
Time frame: Up to approximately 24 months
Duration of Response (DOR) According to RECIST 1.1 Based on investigator assessment
Time frame: Up to approximately 24 months
Progression-free Survival (PFS) According to RECIST 1.1 base on investigator assessment
Time frame: Up to approximately 24 months
Disease Control Rate (DCR) According to iRECIST 1.1 base on investigator assessment
Time frame: Up to approximately 24 months
Duration of Response (DOR) According to iRECIST 1.1 base on investigator assessment
Time frame: Up to approximately 24 months
Progression-free Survival (PFS) According to iRECIST 1.1 base on investigator assessment
Time frame: Up to approximately 24 months
Overall Survival (OS)
Time frame: Up to approximately 24 months
Number of Participants Experiencing an Adverse Event (AE)
Time frame: Up to approximately 27 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Derived from this study: PubMed 40082418Wang Y, Lu J, Chong X, Wang C, Chen X, Peng Z, Gu Y, Wang Y, Wang X, Li J, Gong J, Qi C, Yuan J, Lu Z, Lu M, Zhou J, Cao Y, Chen Y, Zhang C, Hou Z, Kou H, Shen L, Zhang X. PD-1 antibody camrelizumab plus apatinib and SOX as first-line treatment in patients with AFP-producing gastric or gastro-esophageal junction adenocarcinoma (CAP 06): a multi-center, single-arm, phase 2 trial. Signal Transduct Target Ther. 2025 Mar 14;10(1):100. doi: 10.1038/s41392-025-02193-z.
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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.
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 plus Apatinib and SOX and Camrelizumab plus Apatinib in people with Gastric Cancer, run by Peking 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 15 inclusion and 19 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 21 Apr 2023. 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 Xiaotian Zhang (86-10-88196175, zhangxiaotianmed@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Response Rate (ORR) According to RECIST 1.1 based on investigator assessment (time frame: Up to approximately 24 months). 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 NCT04609176, 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 21 Apr 2023.