HER2-positive Gastric CancerPhase 2NCT05070598
Camrelizumab Combined With Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer
A Phase 2 study testing Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur in people with HER2-positive Gastric Cancer, run by Shengjing Hospital at 1 site in China.
Trial summary
According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.); Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Gastric Cancer
- What is being tested?
- Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2021to 30 Mar 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
- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre
Who cannot join
- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shengjing Hospital of China Medical University
Shenyang
Nan Zhang, doctor, 18940253560, zhangnan2515@163.com
About this study
Official title: A Prospective, Single-arm, Phase II Study of Camrelizumab Combined With Pyrotinib Maleate, Nab-paclitaxel and Tegafur Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer
According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);
- Conditions
- HER2-positive Gastric Cancer
- Being tested
- Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Camrelizumab +Pyrotinib + Nab-paclitaxel + TegafurDrug
Camrelizumab was given in the first day of each cycle,Nab-paclitaxel was given in the first day of each cycle, Pyrotinib was given everyday of each cycle, Tegafur given in the day 1-14 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur | Experimental | Camrelizumab Q3W d1 Pyrotinib d1-21 Nab-paclitaxel Q3W d1 Tegafur d1-14 Receives: Drug: Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR (Objective control rate)
The rate of CR and PR, determined using RECIST v1.1 criteria
Measured: up to 12 months
Secondary outcomes (3)
DCR (Disease control rate)
The rate of CR, PR plus SD
Measured: up to 12 months
PFS (Progression-Free survival)
From the date Into this study (signed ICF) to tumor progression or death for any
Measured: up to 12 months
OS(Overall survival)
Baseline until death from any cause
Measured: up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start7 Sep 2021
- Primary completion1 Sep 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Gastric CancerStudies of the same condition, open and under way.
- More trials run by Shengjing 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
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caigang Liu, Shengjing Hospital
- Investigators
- Caigang Liu, doctor, Study chair, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070598
- Sponsor's protocol ID
- Shengjing-LCG
- Status last verified
- Sep 2021
- First submitted
- 27 Sep 2021
- Last updated
- 7 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Phase II Study of Camrelizumab Combined With Pyrotinib Maleate, Nab-paclitaxel and Tegafur Chemotherapy in First-line Treatment of HER2-positive Gastric Cancer
- ClinicalTrials.gov ID
- NCT05070598
- Acronym / sponsor ID
- Shengjing-LCG
- Conditions
- HER2-positive Gastric Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 7 Sep 2021 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 7 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.
According to the investigator's judgment, there are concomitant diseases that seriously endanger the patient's safety, or affect the patient's completion of the study (such as uncontrolled hypertension, diabetes, thyroid disease, etc.);
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur | Experimental | Drug: Camrelizumab +Pyrotinib + Nab-paclitaxel + TegafurCamrelizumab Q3W d1 Pyrotinib d1-21 Nab-paclitaxel Q3W d1 Tegafur d1-14 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre
Key exclusion criteria (1 listed)
- rious hepatic and renal impairment, organ function must meet the following requirements: ANC ≥ 1.5 × 109/L; PLT ≥ 90 × 109/L; Hb ≥ 90g/L; TBIL ≤ 1.5 × ULN; ALT and AST ≤1.5 × ULN, ALP ≤ 2.5 × ULN; for patients with liver metastases, ALT and AST ≤ 5 × ULN BUN and Cr ≤ 1 × ULN and cre
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 +Pyrotinib + Nab-paclitaxel + TegafurCamrelizumab was given in the first day of each cycle,Nab-paclitaxel was given in the first day of each cycle, Pyrotinib was given everyday of each cycle, Tegafur given in the day 1-14 of each cycle | Drug | Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur |
Primary outcome
ORR (Objective control rate)
Time frame: up to 12 months
The rate of CR and PR, determined using RECIST v1.1 criteria
3 secondary outcomes
DCR (Disease control rate)
Time frame: up to 12 months
PFS (Progression-Free survival)
Time frame: up to 12 months
OS(Overall survival)
Time frame: up to approximately 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
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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.
Caigang Liu, doctor study chair
Shengjing 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 Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur in people with HER2-positive Gastric Cancer, run by Shengjing 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 1 inclusion and 1 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 7 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 Nan Zhang, doctor (18940253560, zhangnan2515@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (Objective control rate) (time frame: up to 12 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 7 Oct 2021.