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Gastric CancerPhase 2NCT04250948

Efficacy of Perioperative Chemotherapy Plus PD-1 Antibody in the Locally Advanced Gastric Cancer

A Phase 2 study testing JS001, Oxaliplatin and S1 in people with Gastric Cancer and Locally Advanced Solid Tumor, run by Sun Yat-sen University 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 The sponsor has not verified this record for over two years, so it may be out of date.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

For locally advanced gastric cancer (cT3-4aN+M0), neoadjuvant chemotherapy can downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric Cancer, Locally Advanced Solid Tumor
What is being tested?
JS001, Oxaliplatin and S1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteChina
Study dates
12 Oct 2019to 5 Oct 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written (signed) informed consent;
  • Histologically CT/MRI confirmed cT3-4aN+M0 gastric adenocarcinoma;
  • Consent to send tumor tissue from biopsy or resection for PD-L1, EBV, MSI detection;
  • Female or male, 18-75 years;
  • ECOG 0-1, no surgery contraindications;
  • Physical condition and adequate organ function to ensure the success of abdominal surgery;
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  • Expected survival ≥3 months;
  • Adequate hematological, liver, renal and coagulation function;
  • 1) Platelet (PLT) count ≥100,000 /mm3; 2) Neutrophil count (ANC) ≥1,500 /mm3; 3) Hemoglobin (Hb) level ≥9.0 g/dl; 4) International normalized ratio (INR) ≤1.5; 5) Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5×ULN; 6) Glycosylated hemoglobin (HbA1c) <7.5%; 7) Total bilirubin (TBIL) level ≤1.5×ULN; 8) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 9) Alkaline phosphatase level ≤2.5×ULN (≤5×ULN in case of liver metastasis); 10) Serum creatinine (Cr) level ≤1.5×ULN and creatinine clearance ≥60 ml/min; 11) Thyroid stimulating hormone (TSH) ≤ULN; 12) Normal serum free thyroid hormone (T4); 13) Normal serum free triiodothyronine (T3); 14) Serum amylase ≤1.5×ULN; 15) Lipase ≤1.5×ULN.
  • 9.Females of child bearing age must have a negative pregnancy test, and have to take contraception measures and avoid breast feeding during the study and for 3 months after the last dose; male subjects must agree to taken contraception measures during the study and for 3 months after the last dose.

Who cannot join

  • Known allergy to study drug or excipients, or allergy to similar drugs;
  • Patients with active malignant tumor in recent 2 years, except the tumor studied in this research or cured localized tumor like resected basal cell or squamous cell skin cancer, superficial bladder cancer, cervical or breast carcinoma in situ;
  • Uncontrollable pleural effusion, pericardial effusion, or ascites in 2 weeks before recruitment;
  • Weight loss >20% within 2 weeks before recruitment;
  • Unable to swallow study drug;
  • Prior chemotherapy, radiotherapy, surgery for gastric cancer;
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  • Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent;
  • Prior therapy with tyrosine kinase inhibitor within 2 weeks.
  • Concurrent medical condition requiring the use of cortisol (>10mg/day Prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. Except: inhalation or topical corticosteroids. Doses > 10 mg/day prednisone or equivalent for replacement therapy;
  • Have vaccination with attenuated live vaccines within 4 weeks prior to initiation of the study treatment or plan to vaccinate during the study;
  • Poorly controlled hypertension or diabetes;
  • With bleeding tendency, or evident hemoptysis or other hemorrhagic events (e.g. gastrointestinal hemorrhage, hemorrhagic gastric ulcer) within 2 months prior to initiation of study treatment, or presence of hereditary or acquired bleeding or thrombotic tendency (e.g. hemophilia, coagulopathy, thrombocytopenia, etc.), or current/long-term thrombolytic or anticoagulant therapy (except aspirin ≤100 mg/day);
  • Present or history of any autoimmune disease;
  • With active tuberculosis or receiving previous anti-tuberculosis therapy within one year;
  • Diagnosed with interstitial pneumonia, non-infectious pneumonia, pulmonary fibrosis, acute lung disease;
  • Pregnancy or breast feeding;
  • Human immunodeficiency virus (HIV) infection (HIV antibody positive), or active hepatitis C virus (HCV) infection (HCV antibody positive), or active hepatitis B virus (HBV) infection (HBsAg or HBcAb positive, and HBV-DNA ≥2000 IU/ml (copies/ml)), or other severe infection requiring systemic antibiotic treatment, or unexplained body temperature >38.5℃ during screening period/before study treatment;
  • Patients with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

Other trials in China

About this study

Official title: Perioperative Chemotherapy Plus PD-1 Antibody Compared With Perioperative Chemotherapy in the Locally Advanced Gastric Cancer: a Open-label, Phase 2 Randomised Controlled Trial

For locally advanced gastric cancer (cT3-4aN+M0), neoadjuvant chemotherapy can downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. JS001 in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate tolerability, safety and efficacy of JS001 in combination with perioperative chemotherapy in locally advanced gastric cancer.

Read the detailed description

Gastric cancer is one of the most common malignancies in China with incidence and mortality both ranking the 2nd among malignancies in China. Surgery is the only possible way to cure gastric cancer, however, over 80-90% of gastric cancer patients in China are in advanced stage. Locally advanced gastric cancer (cT3-4aN+M0) could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. Neoadjuvant chemotherapy can downstage T and N stage, increase the resectability of tumor, and finally improve the long-term survival. However, the therapeutic effects remain unsatisfactory. PD-1 antibody has demonstrated its efficacy in metastatic gastric cancer and has been proved to be effective in neoadjuvant setting in lung cancer and melanoma. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced gastric cancer could be a novel therapy to increase response rate and resectability and reduce recurrence rate. JS001 in this study is a Chinese anti-PD-1 monoclonal antibody for injection which has been approved for melanoma. This study is a multi-center, open-label, randomized phase II clinical trial to evaluate tolerability, safety and efficacy of JS001 in combination with perioperative chemotherapy in locally advanced gastric cancer.

Being tested
JS001, Oxaliplatin, S1, Capecitabine
Keywords
Perioperative Therapy, PD-1 antibody, Gastric Cancer
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • JS001Drug

    Also called PD-1 antibody

    JS001, recombinant humanized anti-PD-1 monoclonal antibody for injection; 240mg ivdrip, d1, q3w.

  • OxaliplatinDrug

    Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w

  • S1Drug

    S-1: 40~60mg Bid，d1~14, q3w

  • CapecitabineDrug

    Also called XELODA

    Capecitabine: 1000mg/m2 Bid，d1-14, q3w

Study groups in NCT04250948
Study groupRoleWhat they receive
XELOX or SOXActive comparatorXELOX: Oxaliplatin+Capecitabine; SOX: Oxaliplatin+S-1 Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w; S-1:40~60mg Bid, d1~14, q3w; Capecitabine: 1000mg/m2 Bid, d1-14, q3w; Neoadjuvant chemotherapy for 3 cycles, adjuvant chemotherapy for 5 cycles.
Receives: Drug: Oxaliplatin; Drug: S1; Drug: Capecitabine
JS001+XELOX or SOXExperimentalXELOX: Oxaliplatin+Capecitabine; SOX: Oxaliplatin+S-1 JS001: 240mg, ivdrip, d1, q3w; S-1:40~60mg Bid, d1~14, q3w; Capecitabine: 1000mg/m2 Bid, d1-14, q3w; Neoadjuvant chemotherapy for 3 cycles, adjuvant chemotherapy for 5 cycles.
Receives: Drug: JS001; Drug: Oxaliplatin; Drug: S1; Drug: Capecitabine

What is being measured

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

  1. TRG0/1

    Pathological tumor regression grade 0/1

    Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

Secondary outcomes (6)

  1. pCR

    Pathological complete response

    Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

  2. R0 resection rate

    Rate of microscopically margin-negative resection

    Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.

  3. Recurrence free survival (RFS)

    The Kaplan-Meier survival from the initiation date of first cycle until the date of first documented recurrence

    Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

  4. Objective response rate (ORR)

    Defined as the proportion of patients whose tumors shrink for a certain period of time

    Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

  5. Disease control rate (DCR)

    Defined as the proportion of patients whose tumors shrink or remain stable for a certain period of time

    Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years]

  6. Overall survival (OS)

    The Kaplan-Meier survival from the initiation date of first cycle until death from any cause or the last follow-up date.

    Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of first documented progression or date of death from any cause, whichever came first, assessed up to 3 years

Timeline

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

  1. First posted31 Jan 2020
  2. Study start12 Oct 2019
  3. Primary completion27 Jun 2022
  4. Study completion5 Oct 2024 (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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04250948
Sponsor's protocol ID
Neoadjuvant PD-1/LAGC
Status last verified
Jul 2023
First submitted
10 Nov 2019
Last updated
1 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yuan SQ, Nie RC, Jin Y, Liang CC, Li YF, Jian R, Sun XW, Chen YB, Guan WL, Wang ZX, Qiu HB, Wang W, Chen S, Zhang DS, Ling YH, Xi SY, Cai MY, Huang CY, Yang QX, Liu ZM, Guan YX, Chen YM, Li JB, Tang XW, Peng JS, Zhou ZW, Xu RH, Wang F. Perioperative toripalimab and chemotherapy in locally advanced gastric or gastro-esophageal junction cancer: a randomized phase 2 trial. Nat Med. 2024 Feb;30(2):552-559. doi: 10.1038/s41591-023-02721-w. Epub 2024 Jan 2.

    PubMed 38167937

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing JS001, Oxaliplatin and S1 in people with Gastric Cancer and Locally Advanced Solid Tumor, run by Sun Yat-sen University 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 10 inclusion and 18 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 1 Aug 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. 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?

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?

TRG0/1 (time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 12 weeks.). 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 NCT04250948, 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 1 Aug 2023.

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