Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

A Phase 2 study testing Camrelizumab Nab-Paclitaxel S-1 in people with Gastric Cancer, run by Hebei Medical University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Trial summary

The purpose of this study is to investigate the efficacy and safety of intraperitoneal and intravenous nab-paclitaxel plus Camrelizumab and S-1 conversion therapy for gastric cancer with positive exfoliative cancer cells. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Gastric Cancer
What is being tested?: Camrelizumab Nab-Paclitaxel S-1
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: No sites listed yet
Study dates: 30 Jun 2022to 30 Jun 2025
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 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

None previous chemotherapy, radiotherapy and other antitumor therapy;
Age:18 to 70 years old;
Man or female (except pregnant and lactating women);
Conﬁrmed to gastric adenocarcinoma and HER2-negative;
Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;
Blood cell count has to meet the following certeria:

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WBC≥3.5×109/L; ANC≥1.5×109/L; PLT≥100×109/L; HB≥90g/L;
Liver/kidney function has to meet the following certeria:
ALT and AST≤2.5×ULN TBIL<1.5×ULN； Serum creatinine ≤1.5×ULN;
Left ventricular ejection fraction (LVEF) ≥50%;
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
Participants were willing to join in this study, good adherence and written informed consent.

Who cannot join

Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
Patients with other malignant tumors within 5 years;
Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study;
Distant metastasis;
It has serious or uncontrolled medical diseases and infections (Including atrial fibrillation, angina pectoris, cardiac insufficiency, ejection fraction less than 50%, poor-controlled hypertension and so on);

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History of psychiatric drugs abuse and can't quit or patients with mental disorders;
Patients with severe or uncontrollable mental illness;
It have serious harm to the patient's safety or affect the patients who have completed the research.
The researchers think inappropriate.

Trial locations and contacts

No sites are listed yet.

Qun Zhao, Professor contact

13930162111

Zhaoqun516@126.com

About this study

Official title: A Prospective Study of Intraperitoneal and Intravenous Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells

Conditions: Gastric Cancer
Being tested: Camrelizumab Nab-Paclitaxel S-1
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 Nab-Paclitaxel S-1Drug
Camrelizumab+S-1+Intraperitoneal nab-paclitaxel and intravenous nab-paclitaxel

Study groups in NCT05410847
Study group	Role	What they receive
Experimental	Experimental	Camrelizumab: 200mg，iv，30min, q3w, 4 cycles. Nab-Paclitaxel: intraperitoneal nab-paclitaxel 80 mg/m2 and intravenous nab-paclitaxel 180 mg/m2 on days 1, q3w, 4 cycles. S-1：According to the body surface area, BSA <1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week, q3w, 4 cycles. For patients who were operable, the original regimen was continued for 4 cycles of adjuvant treatment after operation, followed by maintenance of carrelizumab monotherapy to 1 year. Inoperable patients were selected for follow-up treatment according to guidelines recommended by the investigator. Receives: Drug: Camrelizumab Nab-Paclitaxel S-1

What is being measured

The primary outcome is the main question the study is designed to answer.

R0-resection rate
There was no residual by the microscope
Measured: within 3 weeks after surgery
Conversion to negative rate
Exfoliative cytology positive gastric cancer conversion to negative rate
Measured: within 3 weeks after surgery

Secondary outcomes (6)

Overall survival (OS)
Baseline to measured date of death from any cause
Measured: 3years
Progression free survival (PFS)
Baseline to measured date of progression or death from any cause
Measured: 3years
Objective response rate (ORR)
Baseline to measured stable disease
Measured: tumor assessment every 6 weeks since the treatment began，up to 3years
Disease control rate (DCR)
Baseline to measured progressive disease
Measured: tumor assessment every 6 weeks since the treatment began，up to 3years
Tumor regression grade (TRG)
TRG included four grades: Grade 0-3
Measured: within 3 weeks after surgery
Adverse events
Toxicity according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0. The number of Participants with adverse events will be recorded at each treatment visit.
Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jun 202230 Jun 2025

First posted8 Jun 2022
Study start30 Jun 2022 (estimated)
Primary completion30 Jun 2023 (estimated)
Study completion30 Jun 2025 (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.
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: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05410847
Sponsor's protocol ID: HRCG-001
Status last verified: Jun 2022
First submitted: 6 Jun 2022
Last updated: 24 Jun 2022
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lv J, Wu J, Wu H, Ding P, Guo H, Yang P, Tian Y, Liu Y, Zhao Q. Study protocol of a phase II clinical trial evaluating the efficacy of neoadjuvant intraperitoneal and systemic albumin-bound paclitaxel combined with camrelizumab and S-1 in the treatment of patients with exfoliative cell-positive gastric cancer. Front Oncol. 2023 Sep 29;13:1201928. doi: 10.3389/fonc.2023.1201928. eCollection 2023.
PubMed 37841441

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective Study of Intraperitoneal and Intravenous Nab-paclitaxel Plus Camrelizumab and S-1 Conversion Therapy for Gastric Cancer With Positive Exfoliative Cancer Cells
ClinicalTrials.gov ID: NCT05410847
Acronym / sponsor ID: HRCG-001
Conditions: Gastric Cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 30 participants (estimated)
Lead sponsor: Hebei Medical UniversityUniversity, hospital or other
Study start: 30 Jun 2022 (estimated)
Primary completion: 30 Jun 2023 (estimated)
Study completion: 30 Jun 2025 (estimated)
First posted: 8 Jun 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental	Experimental	Drug: Camrelizumab Nab-Paclitaxel S-1Camrelizumab: 200mg，iv，30min, q3w, 4 cycles. Nab-Paclitaxel: intraperitoneal nab-paclitaxel 80 mg/m2 and intravenous nab-paclitaxel 180 mg/m2 on days 1, q3w, 4 cycles. S-1：According to the body surface area, BSA <1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week, q3w, 4 cycles. For patients who were operable, the original regimen was continued for 4 cycles of adjuvant treatment after operation, followed by maintenance of carrelizumab monotherapy to 1 year. Inoperable patients were selected for follow-up treatment according to guidelines recommended by the investigator.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (12 listed)

None previous chemotherapy, radiotherapy and other antitumor therapy;
Age:18 to 70 years old;
Man or female (except pregnant and lactating women);
Conﬁrmed to gastric adenocarcinoma and HER2-negative;
Proven gastric cancer of T stage was T3 and T4, and no distant metastasis was observed. The exfoliative cancer cells detection in peritoneal washes was positive;

Key exclusion criteria (10 listed)

Subjects with immunosuppressive medications within 14 days of first administration of study treatment, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroid hormones (no more than 10 mg / day of prednisolone or other corticosteroids of equivalent pharmaceutical physiological dose);
The patient has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, pituitary inflammation, vasculitis, nephritis, hyperthyroidism, hypothyroidism; patients with vitiligo; Asthma has been completely relieved in childhood, and patients who do not need any intervention after adulthood can be included; asthma patients who require bronchodilators for medical intervention cannot be included);
Patients with other malignant tumors within 5 years;
Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV-DNA ≥1000 IU/ml) or hepatitis C (positive hepatitis C antibody, and HCV-RNA is higher than the lower limit of detection of the analytical method) or co-infection with hepatitis B and C, requiring antiviral treatment during the study;
Distant metastasis;

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 Nab-Paclitaxel S-1Camrelizumab+S-1+Intraperitoneal nab-paclitaxel and intravenous nab-paclitaxel	Drug	Experimental

Primary outcome

R0-resection rate
Time frame: within 3 weeks after surgery
There was no residual by the microscope
Conversion to negative rate
Time frame: within 3 weeks after surgery
Exfoliative cytology positive gastric cancer conversion to negative rate

6 secondary outcomes

Overall survival (OS)
Time frame: 3years
Progression free survival (PFS)
Time frame: 3years
Objective response rate (ORR)
Time frame: tumor assessment every 6 weeks since the treatment began，up to 3years
Disease control rate (DCR)
Time frame: tumor assessment every 6 weeks since the treatment began，up to 3years
Tumor regression grade (TRG)
Time frame: within 3 weeks after surgery
Adverse events
Time frame: 3 years

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
Derived from this study: PubMed 37841441Lv J, Wu J, Wu H, Ding P, Guo H, Yang P, Tian Y, Liu Y, Zhao Q. Study protocol of a phase II clinical trial evaluating the efficacy of neoadjuvant intraperitoneal and systemic albumin-bound paclitaxel combined with camrelizumab and S-1 in the treatment of patients with exfoliative cell-positive gastric cancer. Front Oncol. 2023 Sep 29;13:1201928. doi: 10.3389/fonc.2023.1201928. eCollection 2023.
Individual participant dataSharing planned: No

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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.

Qun Zhao, Professor contact

13930162111

Zhaoqun516@126.com

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab Nab-Paclitaxel S-1 in people with Gastric Cancer, run by Hebei Medical University.

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 12 inclusion and 10 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 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

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 Qun Zhao, Professor (13930162111, Zhaoqun516@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

R0-resection rate (time frame: within 3 weeks after surgery). The study lists 2 primary outcomes in all. 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 NCT05410847, 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 24 Jun 2022.