Gastric CancerPhase 1/2NCT05101616
A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer
A Phase 1/2 study testing camrelizumab+chemotherapy and Chemotherapy in people with Gastric Cancer, run by Shanghai Minimally Invasive Surgery Center at 1 site in China.
Trial summary
It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- camrelizumab+chemotherapy and Chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Jan 2027
- Phase
- Phase 1/2
- 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
- Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
- Male or female patients between the ages of 18-75;
- Patients diagnosed as gastric adenocarcinoma by histology or cytology;
- Stage: Locally advanced stage (T3-4aN1-3M0);
- Have not received other immunotherapy drugs or chemotherapy drugs in the past;
- ECOG (Eastern US Cooperative Oncology Group) score: 0-1 points;
- Has sufficient organ and bone marrow function
Who cannot join
- Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)];
- A distant metastasis occurs;
- Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
- Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
- Patients with any severe and/or uncontrollable disease；
- Patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction
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- Patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study;
- Received glucocorticosteroid or immunosuppressive therapy within 7 days before grouping;
- Regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events NCI-CTC AE V5.0 grade ≥ 3, unhealed wounds, ulcers Or fracture
- Those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism;
- People with a history of psychotropic drug abuse and unable to quit or have mental disorders;
- Participated in other anti-tumor drug clinical trials within four weeks;
- According to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study;
- Female patients who are pregnant or breastfeeding;
- Known hypersensitivity to any study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer: a Single-center, Open-label, Randomized Controlled Trial
It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.
- Conditions
- Gastric Cancer
- Being tested
- camrelizumab+chemotherapy, Chemotherapy
- Keywords
- gastric cancer, neoadjuvant chemotherapy, immunotherapy
- 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+chemotherapyDrug
camrelizumab 200mg，ivdrip，q3w； albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip，d1，q3w； oxaliplatine 85mg/m2、ivdrip，d1，q3w； S-1 40 mg/m2，po, bid，d1~d14，q3w. 3 cycles.
ChemotherapyDrug
albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip，d1，q3w； oxaliplatine 85mg/m2、ivdrip，d1，q3w； S-1 40 mg/m2，po, bid，d1~d14，q3w. 3 cycles.
| Study group | Role | What they receive |
|---|---|---|
| camrelizumab+chemotherapy | Experimental | neoadjuvant treatment with camrelizumab+chemotherapy Receives: Drug: camrelizumab+chemotherapy |
| chemotherapy | Active comparator | neoadjuvant treatment with chemotherapy Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
major pathologic response rate
complete or subtotal regression (<10% residual tumor per tumor bed)
Measured: one month after surgery
Secondary outcomes (5)
complete pathologic response rate
complete regression (no residual tumor per tumor bed)
Measured: one month after surgery
R0 resection rate
surgically removed tissue without residual cancer cells
Measured: one month after surgery
Overall survival
the time from the start of randomization to death due to any cause.
Measured: 3 years
Disease-free survival
the time from the start of randomization to the incurable resection, local recurrence or metastasis, or death from any cause.
Measured: 3 years
perioperative complications
perioperative complications
Measured: the time from the start of randomization to 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start1 Jul 2022
- Primary completion1 Jan 2025 (estimated)
- Study completion1 Jan 2027 (estimated)
Why it stopped: difficult in enrolling participants
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101616
- Sponsor's protocol ID
- Camrelizumab-GC-neoadjuvant
- Status last verified
- Mar 2024
- First submitted
- 28 Oct 2021
- Last updated
- 7 Mar 2024
- 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 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Neoadjuvant Chemotherapy With or Without Camrelizumab for Locally Advanced Gastric Cancer: a Single-center, Open-label, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05101616
- Acronym / sponsor ID
- Camrelizumab-GC-neoadjuvant
- Conditions
- Gastric Cancer
- Keywords
- gastric cancer, neoadjuvant chemotherapy, immunotherapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: difficult in enrolling participants
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2025 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 1 Nov 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.
It is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of Camrelizumab combined with DOS regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| camrelizumab+chemotherapy | Experimental | Drug: camrelizumab+chemotherapyneoadjuvant treatment with camrelizumab+chemotherapy |
| chemotherapy | Active comparator | Drug: Chemotherapyneoadjuvant treatment with chemotherapy |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up;
- Male or female patients between the ages of 18-75;
- Patients diagnosed as gastric adenocarcinoma by histology or cytology;
- Stage: Locally advanced stage (T3-4aN1-3M0);
- Have not received other immunotherapy drugs or chemotherapy drugs in the past;
Key exclusion criteria (15 listed)
- Other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) ) And T1 (tumor infiltration basement membrane)];
- A distant metastasis occurs;
- Those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.);
- Accompanied by pleural effusion or ascites, causing respiratory syndrome (NCI-CTC AE V5.0 grade ≥ 2 dyspnea);
- Patients with any severe and/or uncontrollable disease；
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+chemotherapycamrelizumab 200mg，ivdrip，q3w； albumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip，d1，q3w； oxaliplatine 85mg/m2、ivdrip，d1，q3w； S-1 40 mg/m2，po, bid，d1~d14，q3w. 3 cycles. | Drug | camrelizumab+chemotherapy |
| Chemotherapyalbumin nanoparticle of paclitaxel 260 mg/m2、 ivdrip，d1，q3w； oxaliplatine 85mg/m2、ivdrip，d1，q3w； S-1 40 mg/m2，po, bid，d1~d14，q3w. 3 cycles. | Drug | chemotherapy |
Primary outcome
major pathologic response rate
Time frame: one month after surgery
complete or subtotal regression (<10% residual tumor per tumor bed)
5 secondary outcomes
complete pathologic response rate
Time frame: one month after surgery
R0 resection rate
Time frame: one month after surgery
Overall survival
Time frame: 3 years
Disease-free survival
Time frame: 3 years
perioperative complications
Time frame: the time from the start of randomization to 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing camrelizumab+chemotherapy and Chemotherapy in people with Gastric Cancer, run by Shanghai Minimally Invasive Surgery Center 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 7 inclusion and 15 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: paused, as of the sponsor's last update on 7 Mar 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
major pathologic response rate (time frame: one month after surgery). 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 Mar 2024.