Advanced Gastric CarcinomaPhase 2NCT05313906
RC48 Plus AK105 and Cisplatin in Advanced Gastric Cancer
A Phase 2 study testing RC48+AK105+cisplatin in people with Advanced Gastric Carcinoma and HER2-positive Gastric Cancer, run by Henan Cancer Hospital at 1 site in China.
Trial summary
To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Gastric Carcinoma, HER2-positive Gastric Cancer
- What is being tested?
- RC48+AK105+cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 7 May 2022to 30 Apr 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years old, ≤75 years old, regardless gender
- Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+
- ECOG PS scores 0-1
- Stage IV according to AJCC 8.0 and no systemic therapy previously
- Expected lifespan ≥ 3 months
- Adequate organ function
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- At least one measurable lesion according to RECIST 1.1
- Asymptomatic intracranial metastasis
- No history of other malignancies
- Women of childbearing age must have a negative blood pregnancy test within 7 days, and subjects of childbearing age must use appropriate contraception during the trial and for 6 months after the trial
- Agreed to participate in this clinical study and signed the Informed Consent
Who cannot join
- Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose
- Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor
- Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration
- Active autoimmune diseases or immunodeficiency diseases
- Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug
- Severe mental disorder
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- Receiving systemic corticosteroids within 7 days prior to the first dose of the study
- Clinically apparent cardiovascular and cerebrovascular disease
- Others investigators evaluated not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
China1 site
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, 450008
About this study
Official title: Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer
To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer.
Read the detailed description
Although anti-PD-1 antibody could prolong the survival of patients with adanced gastic cancer, there are relatively few reports on anti-PD-1 antibody therapy in Her2-positive gastric cancer. RC48 is a primary anti-HER2 antibody-drug conjugate, which has been approved by the Chinese NMPA for the later-line treatment of Her2-positive gastric cancer. This study was to explore the safety and clinical efficacy of RC48 combined with cisplatin and AK105 in previously untreated patients with HER2-positive gastric cancer.
- Being tested
- RC48+AK105+cisplatin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RC48+AK105+cisplatinDrug
RC48 plus AK105 and cisplatin
| Study group | Role | What they receive |
|---|---|---|
| exprimental group | Experimental | RC48 plus AK105 and cisplatin Receives: Drug: RC48+AK105+cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
the proportion of patients who got CR and PR
Measured: three months
Secondary outcomes (2)
PFS
the duration of diseases stable or better
Measured: six months and twelve months
DCR
the proportion of patients who got CR, PR and SD
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start7 May 2022 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Gastric CarcinomaStudies of the same condition, open and under way.
- More trials run by Henan Cancer 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
- Model description
- RC48 plus AK105 and cisplatin
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Collaborators
- Rongchang Biopharmaceutical, Zhengda Tianqing Pharmaceutical Group Co., Ltd.
- Responsible party
- Principal investigator, Quanli Gao, Henan Cancer Hospital
- Investigators
- Quanli Gao, Dr, Principal investigator, Henan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313906
- Sponsor's protocol ID
- HenanCH immunotherapy007
- Status last verified
- Mar 2022
- First submitted
- 29 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disitamab Vedotin Plus Penpulimab and Cisplatin in Advanced Gastric Cancer
- ClinicalTrials.gov ID
- NCT05313906
- Acronym / sponsor ID
- HenanCH immunotherapy007
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Collaborators
- Rongchang Biopharmaceutical, Zhengda Tianqing Pharmaceutical Group Co., Ltd.
- Study start
- 7 May 2022 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 6 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.
To explore the safety and clinical efficacy of cisplatin combined with RC48 and anti-PD-1 antibodies AK105 in Her-2 positive advanced gastric cancer.
Detailed description
Although anti-PD-1 antibody could prolong the survival of patients with adanced gastic cancer, there are relatively few reports on anti-PD-1 antibody therapy in Her2-positive gastric cancer. RC48 is a primary anti-HER2 antibody-drug conjugate, which has been approved by the Chinese NMPA for the later-line treatment of Her2-positive gastric cancer. This study was to explore the safety and clinical efficacy of RC48 combined with cisplatin and AK105 in previously untreated patients with HER2-positive gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- RC48 plus AK105 and cisplatin
| Arm | Type | Receives |
|---|---|---|
| exprimental group | Experimental | Drug: RC48+AK105+cisplatinRC48 plus AK105 and cisplatin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥18 years old, ≤75 years old, regardless gender
- Pathologically confirmed gastric adenocarcinoma, Her2 immunohistochemical examination of 2+ or 3+
- ECOG PS scores 0-1
- Stage IV according to AJCC 8.0 and no systemic therapy previously
- Expected lifespan ≥ 3 months
Key exclusion criteria (9 listed)
- Currently participating in an interventional clinical investigational treatment, or have received other investigational drugs or treatment with an investigational device within 4 weeks prior to the first dose
- Received anti-PD-1, anti-PD-L1, anti-CTLA-4, and other checkpoint inhibitor
- Received traditional Chinese medicines or immunomodulatory drugs with anti-gastric cancer indications within 2 weeks before the first administration
- Active autoimmune diseases or immunodeficiency diseases
- Allergy to any test drug and its excipients, or a history of severe allergy, or contraindication to the test drug
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 |
|---|---|---|
| RC48+AK105+cisplatinRC48 plus AK105 and cisplatin | Drug | exprimental group |
Primary outcome
ORR
Time frame: three months
the proportion of patients who got CR and PR
2 secondary outcomes
PFS
Time frame: six months and twelve months
DCR
Time frame: three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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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.
Quanli Gao, Dr principal investigator
Henan Provincial People's Hospital
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 RC48+AK105+cisplatin in people with Advanced Gastric Carcinoma and HER2-positive Gastric Cancer, run by Henan Cancer 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 11 inclusion and 9 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 6 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 Quanli Gao, Dr (+8637165587795, zlyygql0855@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: three 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 6 Apr 2022.