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Advanced Gastric AdenocarcinomaNCT04675866

Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the Treatment of Advanced Gastric Cancer

A study testing Camrelizumab, Albumin-bound paclitaxel, S-1 in people with Advanced Gastric Adenocarcinoma, run by Henan Cancer Hospital at 1 site in China.

Unknown status

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 The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The purpose of this study is to investigate the safety and efficacy of Camrelizumab combined with paclitaxel (albumin binding type) and S-1 for first-line treatment of advanced gastric cancer, and to further explore the curative effect of PD - L1 expression in tumor tissue, EBV virus content, microsatellite… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Gastric Adenocarcinoma
What is being tested?
Camrelizumab, Albumin-bound paclitaxel, S-1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
17 Aug 2020to 31 Dec 2023
Phase
Interventional
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 18-75 years old, no gender limit.
  • ECOG 0-1; estimated survival time ≥12 weeks.
  • Histopathologically confirmed unresectable locally advanced or metastatic HER-2 negative gastric adenocarcinoma.
  • At least one measurable lesion (RECIST1.1 standard).
  • Have not received systemic treatment for inoperable or metastatic gastric adenocarcinoma, past (new) adjuvant chemotherapy and adjuvant radiotherapy treatment ended to enrollment> 6 months.
  • For local lesions (non-target lesions) palliative treatment (mainly local radiotherapy) end time to random entry time> 2 weeks.
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  • The main organs and bone marrow function are basically normal:
  • Routine blood: neutrophils ≥1.5×109/L, platelets ≥100×109/L, hemoglobin ≥80g/L;
  • Liver function: TBiL≤1.5×ULN; ALT/AST≤2.5×ULN (for patients with liver metastases, ≤5ULN);
  • Renal function: serum creatinine≤1.5×ULN and creatinine clearance rate>60mL/min;
  • INR≤1.5×ULN and activated partial thromboplastin time ≤1.5×ULN.
  • Voluntary participation in the clinical study; fully understands and is informed of the study and has signed the Informed Consent Form (ICF); willing to comply with and able to complete all trial procedures.
  • Female subjects of childbearing age or male subjects whose sexual partners are females of childbearing age shall take effective contraceptive measures throughout the treatment period and 6 months after the treatment period.

Who cannot join

  • Patients with symptomatic central nervous system disease or meningeal metastasis; for patients with brain metastases who have received previous treatment, if the clinical condition is stable and imaging evidence does not show disease progression within 4 weeks before the first treatment, they can be considered for inclusion.
  • Patients who have previously been treated with albumin-bound paclitaxel or paclitaxel.
  • Received major surgery (craniotomy, thoracotomy or laparotomy), open biopsy or major traumatic injury within 28 days before enrollment, or expected major surgery during the study treatment period.
  • Suffered from other malignant tumors in the past 5 years (except for cured skin basal cell or squamous cell carcinoma, or carcinoma in situ such as cervix and breast).
  • The investigator believes that it will affect the subjects' ability to receive the treatment of the study protocol and are not controlled for serious medical diseases, such as combined serious medical diseases, including severe heart disease, cerebrovascular disease, uncontrolled diabetes, uncontrolled high blood pressure, Active peptic ulcer, severe infection, etc.
  • Symptomatic congestive heart failure or cardiac color Doppler ultrasound examination shows LVEF (left ventricular ejection fraction <50%).
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  • Any arterial thromboembolic events, including unstable angina pectoris and cerebrovascular accidents, occurred within 6 months before being selected for treatment.
  • A history of deep vein thrombosis, pulmonary embolism or any other serious thromboembolism within 3 months before enrollment.
  • Participate in other clinical trials 28 days before enrollment, unless participating in observational (non-interventional) clinical research or in the follow-up phase of interventional research.
  • Patients with a history of interstitial lung disease, non-infectious pneumonia, or active tuberculosis.
  • Patients with congenital or acquired immune deficiency, active hepatitis B or C.
  • The patient is using immunosuppressive agents or systemic hormone therapy to achieve immunosuppressive purposes. Those who are still using it within 2 weeks before enrollment.
  • Patients with difficult-to-control effusion, accompanied by severe pleural effusion, abdominal effusion and other clinical symptoms.
  • Patients with grade ≥ 2 sensory or motor neuropathy; patients with peripheral neuropathy NCT-CTCAE ≥ 2.
  • People with a history of psychotropic drug abuse and unable to quit or patients with mental disorders.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Henan Tumor Hospital

    Luoyang, Henan, 450000

    Hou xinfang Hou, Doctor, 15136130286, 929700390@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Phase II Clinical Study of Camrelizumab Combined With Albumin-bound Paclitaxel and S-1 in the First-line Treatment of Advanced Gastric and Gastroesophageal Junction Adenocarcinoma

The purpose of this study is to investigate the safety and efficacy of Camrelizumab combined with paclitaxel (albumin binding type) and S-1 for first-line treatment of advanced gastric cancer, and to further explore the curative effect of PD - L1 expression in tumor tissue, EBV virus content, microsatellite instability (MSI), DNA mismatch repair (MMR), tumor mutation load (TMB), lymphocyte subgroup and cytokines.

Read the detailed description

Gastric cancer is a common malignant tumor of digestive tract.The incidence of gastric cancer in China accounts for about half of the world's total, the incidence rate ranks second, and the mortality rate ranks second.Moreover, the proportion of early gastric cancer in China is very low, only about 20%. Most of them are in advanced stage at the time of discovery. The overall 5-year survival rate is less than 15%, which seriously threatens the health and life of Chinese people.For nearly 90% of HER2 negative patients with advanced gastric and gastroesophageal junction adenocarcinoma (g / GEJ), the current first-line treatment option is chemotherapy, and the efficacy of available drugs is very limited.The ORR of the first-line chemotherapy is about 40%, and the OS is about 10 months. New therapeutic drugs are urgently needed to improve the efficacy of advanced G/GEJ.The purpose of this study was to investigate the safety and efficacy of Camrelizumab combined with paclitaxel (albumin binding type) and S-1 for first-line treatment of advanced gastric cancer.

Being tested
Camrelizumab, Albumin-bound paclitaxel, S-1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camrelizumab, Albumin-bound paclitaxel, S-1Other

    Camrelizumab: 200mg, iv, Q3W, d1; Albumin-bound paclitaxel: 125mg/m2, iv, d1, 8, Q3W; S-1: According to the patient's body surface area, the dosage is set to 40, 50, 60 mg/time, bid, po, taking 2 weeks, and stopping the drug for 1 week as a cycle.

Study groups in NCT04675866
Study groupRoleWhat they receive
camrelizumab+albumin-bound paclitaxel+S-1Experimentalcamrelizumab+albumin-bound paclitaxel+S-1
Receives: Other: Camrelizumab, Albumin-bound paclitaxel, S-1

What is being measured

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

  1. Objective response rate (ORR)

    Defined as the proportion of patients with a documented complete response, and partial response (CR+PR).

    Measured: up to 2 years

Secondary outcomes (3)

  1. Disease control rate (DcR)

    defined as the proportion of patients with complete response, partial response and disease stabilization (CR+PR+SD).

    Measured: up to 2 years

  2. Overall survival (OS)

    Defined as the date from random grouping to death from any cause.

    Measured: up to 2 years

  3. Progression free survival (PFS)

    Defined as the time betwween the onset of treatment and the observation of disease progression or death from any cause.

    Measured: up to 2 years

Timeline

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

  1. First posted19 Dec 2020
  2. Study start17 Aug 2020
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04675866
Sponsor's protocol ID
YXGC-001
Status last verified
Nov 2021
First submitted
14 Dec 2020
Last updated
15 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Wu C, Li S, Hou X. Camrelizumab plus albumin-bound paclitaxel and S-1 as first-line treatment for patients with human epidermal growth factor receptor 2-negative advanced gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial. Front Immunol. 2026 Jan 2;16:1634502. doi: 10.3389/fimmu.2025.1634502. eCollection 2025.

    PubMed 41550955

Questions about this trial

What is this clinical trial studying?

A study testing Camrelizumab, Albumin-bound paclitaxel, S-1 in people with Advanced Gastric Adenocarcinoma, 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 13 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: status not confirmed, as of the sponsor's last update on 15 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.

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?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective response rate (ORR) (time frame: up to 2 years). 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 NCT04675866, 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 15 Apr 2022.

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