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Gastric AdenocarcinomaPhase 3NCT03802591

A Study of CS1001 in Subjects With Gastric Adenocarcinoma or Gastro-Esophageal Junction Adenocarcinoma

A Phase 3 study testing CS1001 monoclonal antibody, Oxaliplatin and Capecitabine in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by CStone Pharmaceuticals at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a phase III, multi-Center, randomized, placebo-controlled trial to investigate the efficacy and safety of CS1001 in combination with Oxaliplatin and Capecitabine (CAPOX) chemotherapy in first-line subjects with unresectable locally advanced or metastatic gastric adenocarcinoma (GC) or gastro-esophageal… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
CS1001 monoclonal antibody, Oxaliplatin and Capecitabine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
479 participants
Where
1 siteChina
Study dates
28 Mar 2019to 22 Sep 2023
Phase
Phase 3
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 but ≤ 75 years
  • Being able to follow the protocol requirements as per investigator's evaluation.
  • Provide written informed consent before any protocol-related procedure (that is not a part of subject's routine care) is carried out.
  • Unresectable locally advanced or metastatic gastric carcinoma (GC) or gastro-esophageal junction (GEJ) carcinoma, and have histologically confirmed predominant adenocarcinoma.
  • The subject may have at least a measurable lesion or an evaluable lesion, if not measurable; the investigator will carry out evaluation according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within 28 days prior to randomization.
  • Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1.
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  • Expected survival ≥ 3 months.
  • Subject must not have received systemic treatment (including HER2 inhibitor) for advanced or metastatic gastric carcinoma.
  • Subject must provide tumor tissue samples for biomarker analysis in order to determine the expression of PD-L1. According to central laboratory test, the PD-L1 expression is ≥ 5% in tumor tissue (including PD-L1 expression in tumor cells and tumor infiltrating immune cells).
  • Permitted prior treatment: Subjects with GC or GEJ carcinoma priorly treated with adjuvant or neoadjuvant therapy, who experience clinical progression of disease at least 6 months after last dose are allowed to be enrolled.
  • Subjects must have adequate organ function as assessed in the laboratory tests
  • Subjects with active hepatitis B or active hepatitis C must receive antiviral treatment for at least 14 days prior to the first dose of study treatment and pass the hepatitis B virus (HBV) DNA titer test (≤ 500 IU/mL or 2500 copies/mL) and hepatitis C virus (HCV) RNA test (≤ lower limit of detection) before being enrolled. The subject should be willing to continue effective anti-viral treatment during the study.
  • Female subject with childbearing potential must have negative serum pregnancy test result at screening, except for those with available sterilization operation record or post-menopausal subjects. Female subject with childbearing potential or male subjects and their partners must agree to take effective contraceptive measures from the day of signing ICF till at least 6 months after the last dosing of investigational product.

Who cannot join

  • Known HER-2 positivity.
  • A known additional primary malignancy that occurred within 5 years prior to the first dose of investigational treatment, except for locally curable cancers that have been apparently cured, such as basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast.
  • Known primary central nerve system (CNS) tumor or meningeal metastasis, or unstable CNS metastasis (symptomatic within 4 weeks before first dose of investigational product, requiring corticosteroid treatment, or without radiologic evidence supporting stable status for over 4 weeks prior to the first dose of investigational product).
  • Any severe or uncontrolled systemic disease, for example diabetes mellitus or hypertension, that may increase the risk associated with participation or investigational product administration, or compromise subject's ability to receive investigational product, as per investigator's judgment.
  • Known positive human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS).
  • Has had prior chemotherapy, immune therapy, biological therapy (including cancer vaccine, cytokine therapy or growth factors to control cancer) used as systemic treatment for cancer, within 14 days before the first dose of investigational product.
  • Any prior treatment of antibody/drug that targets at T-cell coregulatory proteins or immune checkpoints pathways(including anti-PD-1, anti-PD-L1, anti-CTLA4, anti-TIM3, anti-LAG3 antibody, etc.).
  • Subjects with conditions that in the investigator's opinion are not suitable for participating in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing

Other trials in China

About this study

Official title: A Multi-Center, Double-Blind, Randomized, Phase III Study of CS1001 in Combination With CAPOX Chemotherapy Compared to Placebo in Combination With CAPOX Chemotherapy in Subjects With Unresectable Locally Advanced or Metastatic GC or GEJ Adenocarcinoma

This is a phase III, multi-Center, randomized, placebo-controlled trial to investigate the efficacy and safety of CS1001 in combination with Oxaliplatin and Capecitabine (CAPOX) chemotherapy in first-line subjects with unresectable locally advanced or metastatic gastric adenocarcinoma (GC) or gastro-esophageal junction (GEJ) adenocarcinoma.

Being tested
CS1001 monoclonal antibody, CS1001 placebo, Oxaliplatin, Capecitabine

What participants receive

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

  • CS1001 monoclonal antibodyDrug

    Participant will receive CS1001 monoclonal antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months

  • CS1001 placeboDrug

    Participant will receive CS1001 placebo antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months

  • OxaliplatinDrug

    Administered as an IV infusion on Day 1 Q3W

  • CapecitabineDrug

    Administered by oral, twice a day on Day 1 - Day 14 of each cycle.

Study groups in NCT03802591
Study groupRoleWhat they receive
CS1001 monoclonal antibodyExperimentalin combination with Oxaliplatin and Capecitabine
Receives: Drug: CS1001 monoclonal antibody; Drug: Oxaliplatin; Drug: Capecitabine
CS1001 placeboPlacebo comparatorin combination with Oxaliplatin and Capecitabine
Receives: Drug: CS1001 placebo; Drug: Oxaliplatin; Drug: Capecitabine

What is being measured

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

  1. Progression-free survival (PFS) evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

    Measured: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months

  2. Overall survival (OS)

    Measured: from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months

Secondary outcomes (5)

  1. Progression-free survival (PFS) evaluated by Blinded Independent Central Review Committee (BICR) according to RECIST v1.1

    Measured: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months

  2. Objective response rate (ORR) evaluated by investigators according to RECIST v1.1

    Measured: from the first dose of treatment until the best response, assessed up to 27 months

  3. Duration of response (DOR) (evaluated by investigators according to RECIST v1.1)

    Measured: from date of first documented objective response until first documented sign of disease progression or death due to any causes, whichever comes first, assessed up to approximately 27 months

  4. Overall survival rate at 12 months and 24 months

    Measured: from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months

  5. Evaluate the safety of CS1001 in combination with CAPOX chemotherapy compared to placebo in combination with CAPOX chemotherapy

    Measured: from the date of randomization to the first date of recorded all-cause death, assessed up to approximately 38 months

Timeline

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

  1. First posted14 Jan 2019
  2. Study start28 Mar 2019
  3. Primary completion9 Jul 2023
  4. Study completion22 Sep 2023

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
479 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03802591
Sponsor's protocol ID
CS1001-303
Status last verified
Nov 2023
First submitted
11 Jan 2019
Last updated
29 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Zhang X, Wang J, Wang G, Zhang Y, Fan Q, Lu C, Hu C, Sun M, Wan Y, Sun S, Wang J, Zhang L, Shu Y, Luo J, Zhu D, Shen Z, Yao S, Shi Q, Yang J, Shen L; GEMSTONE-303 Investigators. First-Line Sugemalimab Plus Chemotherapy for Advanced Gastric Cancer: The GEMSTONE-303 Randomized Clinical Trial. JAMA. 2025 Apr 15;333(15):1305-1314. doi: 10.1001/jama.2024.28463.

    PubMed 39992668

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing CS1001 monoclonal antibody, Oxaliplatin and Capecitabine in people with Gastric Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, run by CStone Pharmaceuticals 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 8 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: finished, as of the sponsor's last update on 29 Nov 2023. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Progression-free survival (PFS) evaluated by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: from the date of randomization to the first date of recorded progression or all-cause death, whichever comes first, assessed up to approximately 27 months). 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 NCT03802591, 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 29 Nov 2023.

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