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Gastric CancerPhase 2NICENCT04744649

Neoadjuvant Immunotherapy and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer Trial

A Phase 2 study testing XELOX or SOX and JS001+XELOX or SOX in people with Gastric Cancer and Stomach Neoplasm, run by Nanfang Hospital, Southern Medical University at 10 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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
Search all trials

Trial summary

For locally advanced esophagogastric junction and gastric cancer (cT3-4aNxM0 or cT2N+M0), neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early before local therapy has begun, 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, Stomach Neoplasm
What is being tested?
XELOX or SOX and JS001+XELOX or SOX
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
10 sitesChina
Study dates
12 Mar 2021to 30 Dec 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;
  • Age ≥ 18 years and ≤75 years.
  • Confirmed gastric and gastroesophageal junction adenocarcinoma by Gastroscopic biopsy histopathological examination.
  • Imaging (CT/MRI) and diagnostic laparoscopy confirmed at the stage of cT3/4a Nx or T2 N+, M0(AJCC 8th) before randomization.
  • confirmed by immunohistochemistry (IHC) staining or genetic and transcriptional profiling detection to meet one of the following conditions:
  • Combined positive score (CPS) of PD-L1 protein expression ≥5.
Show all 19Show fewer
  • Epstein-Barr virus-positive (EBV(+)).
  • mismatch repair-deficient (dMMR).
  • Microsatellite instability-high (MSI-H)
  • The Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1
  • Expected survival period ≥ 12 weeks
  • The main organ function meets the following criteria within 7 days before treatment:
  • Hemoglobin (Hb) level ≥9.0 g/dl
  • Neutrophil count (ANC)≥1.5×l09/L
  • Platelet (PLT) ≥100×109/L
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) level ≤2.5×ULN
  • Alkaline phosphatase(ALP)level ≤2.5×ULN
  • Serum creatinine (Cr) level ≤1.5×ULN and creatinine clearance ≥60 ml/min
  • Thyroid stimulating hormone (TSH) level ≤1×ULN (if abnormal, should require normal serum free thyroid hormone (T4) and Normal serum free triiodothyronine (T3))

Who cannot join

  • Confirmed at stage IV (AJCC 8th) or unresectable by investigator before randomization.
  • Prior chemotherapy, radiotherapy, surgery immunotherapy or molecular targeted therapy for gastric cancer;
  • Patients who have HER2 positive confiemed with IHC3+ or IHC2+ and FISH positive
  • Patients are allergic to study medication and its ingredients
  • Patients with a history of following treatments:
  • Prior therapy with a PD-1, anti-PD-Ligand 1 (PD-L1) or CTLA-4 agent
Show all 18Show fewer
  • Prior therapy with tyrosine kinase inhibitor within 2 weeks.
  • Patients who have participated in other clinical trials of anti-tumor drugs within four weeks
  • Have vaccination with attenuated live vaccines within 4 weeks prior to initiation of the study treatment or plan to vaccinate during the study;
  • 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
  • Patients have experienced or currently has other malignancies within 5 years.
  • Patients have an active or history of autoimmune disease that may recur or require immunosuppressive drugs within 2 weeks or less or during the study. Or have a history of immunodeficiency, including HIV-positive or other acquired, congenital immunodeficiency disease, or a history of organ transplantation
  • 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.
  • Within 2 weeks or 2 weeks before randomization, patients have an active or uncontrollable infection that requires systemic antibiotic treatment
  • Diagnosed with interstitial pneumonia, non-infectious pneumonia, pulmonary fibrosis, acute lung disease;
  • Patients with active tuberculosis or receiving previous anti-tuberculosis therapy within one year
  • Women who are pregnant, breast-feeding or planning to become pregnant during treatment or within 6 months after treatment ends.
  • Patients have a history of psychotropic substance abuse and are unable to quit or have a mental disorder

Trial locations and contacts

10 sites in 1 country.

Guoxin Li, M.D., Ph.D. contact

+86 13802771450

gzliguoxin@163.com

Xinhua Chen, M.D., Ph.D. contact

+86 15626452302

xinhuachen03@163.com

10 sites in 1 country

China10 sites, 10 recruiting

  • Fujian Provincial Hospital

    Fuzhou, Fujian

    Fangqin Xue, +8618750162636

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510-515

    Guoxin Li, M.D., Ph.D., +86-138-0277-1450, gzliguoxin@163.com

    Xinhua Chen, M.D., Ph.D., +86-156-2645-2302, xinhuachen03@163.com

    Recruiting

  • The six affiliated hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510515

    Lei Lian, MD, 15913114265, sabiston@126.com

    Lei Lian, MD

    Recruiting

  • Guangdong Provincial Hospital of Chinese Medicine, the Second Affiliated Hospital of Guangzhou University of Chinese Medicine,

    Guangzhou, Guangdong

    Wei Wang, +8613922255515

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

    Kuan Wang

    Not yet recruiting

  • Mao ming people's hospital

    Maoming, Guangdong

    Dingming Li, +8613500078234

    Not yet recruiting

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

    Guoqing Lv, +8613928404691

    Recruiting

  • The Eighth Affiliated Hospital, Sun Yat-Sen University

    Shenzhen, Guangdong

    Xiaobin Wu, +8613928800055

    Not yet recruiting

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

    Jun You, +8613906051681

    Not yet recruiting

  • Zhongshan People's Hospital

    Zhongshan, Guangdong

    Hong Chen

    Recruiting

Other trials in China

About this study

Official title: Efficacy and Safety of Neoadjuvant Immunotherapy and Chemotherapy for Locally Advanced Esophagogastric Junction and Gastric Cancer : a Open-label, Phase 2 Randomised Controlled Trial (NICE Trial)

For locally advanced esophagogastric junction and gastric cancer (cT3-4aNxM0 or cT2N+M0), neoadjuvant chemotherapy can downstage T and N stage,treated distant micrometastases early before local therapy has begun, and finally improve the long-term survival. Combination of perioperative PD-1 antibody and chemotherapy for locally advanced esophagogastric junction and gastric cancer could be a novel therapy to increase response rate 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 safety and efficacy of JS001 in combination with perioperative chemotherapy in locally advanced esophagogastric junction and gastric cancer. Differences in gut microbiome and tumor immune microenvironment were detected to screen people who were more sensitive to immunotherapy.

Read the detailed description

Gastric cancer (GC) is one of the leading causes of cancer-related deaths worldwide and a substantial global health burden. Surgery is the only possible way to cure gastric cancer, however, more than 80% of the Chinese patients are diagnosed at advanced stages. Locally advanced esophagogastric junction and gastric cancer (cT3-4aNxM0 or cT2N+M0) could be cured by multi-disciplinary therapies including surgery, chemotherapy and radiotherapy. Neoadjuvant chemotherapy can downstage T and N stage, treated distant micrometastases early before local therapy has begun, 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 esophagogastric junction and gastric cancer could be a novel therapy to increase response rate 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 safety and efficacy of JS001 in combination with perioperative chemotherapy in locally advanced esophagogastric junction and gastric cancer. Differences in gut microbiome and tumor immune microenvironment were detected to screen people who were more sensitive to immunotherapy.

Being tested
XELOX or SOX, JS001+XELOX or SOX
Keywords
Gastric Cancer, Esophagogastric Junction Cancer, Immunotherapy and Chemotherapy, Neoadjuvant
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • XELOX or SOXDrug

    Also called Control group

    XELOX: 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 4 cycles, adjuvant chemotherapy for 4 cycles.

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

    Drug: S1 S-1: 40~60mg Bid，d1~14, q3w

    Drug: Capecitabine Capecitabine: 1000mg/m2 Bid, d1-14, q3w Other Name: XELODA

    JS001: 240mg, ivdrip, d1, q3w;

    S-1:40~60mg Bid, d1~14, q3w;

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

    Neoadjuvant chemotherapy for 4 cycles, adjuvant chemotherapy for 4 cycles.

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

    Other Name: PD-1 antibody

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

    Drug: S1 S-1: 40~60mg Bid,d1~14, q3w

    Drug: Capecitabine Capecitabine: 1000mg/m2 Bid, d1-14, q3w Other Name: XELODA

  • JS001+XELOX or SOXDrug

    Also called Experimental group and Exploratory group

    XELOX: 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 4 cycles, adjuvant chemotherapy for 4 cycles.

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

    Other Name: PD-1 antibody

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

    Drug: S1 S-1: 40~60mg Bid,d1~14, q3w

    Drug: Capecitabine Capecitabine: 1000mg/m2 Bid, d1-14, q3w Other Name: XELODA

Study groups in NCT04744649
Study groupRoleWhat they receive
Control groupActive comparatorThe patients with combined positive score (CPS) of PD-L1 protein expression≥5 were randomised to control group(N=40), will receive the neoadjuvant regime of XELOX or SOX. XELOX: 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 4 cycles, adjuvant chemotherapy for 4 cycles.
Receives: Drug: XELOX or SOX
Experimental groupExperimentalThe patients with combined positive score (CPS) of PD-L1 protein expression≥5 were randomised to experimental group(N=40), will receive the neoadjuvant regime of JS001+XELOX or SOX. XELOX: 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 4 cycles, adjuvant chemotherapy for 4 cycles.
Receives: Drug: JS001+XELOX or SOX
Exploratory groupOtherAll the patients of Epstein-Barr virus-positive (EBV(+)) [N=15]or mismatch repair-deficient (dMMR)/ microsatellite instability-high (MSI-H)[N=15] , will be assigned to exploratory group, and will receive the neoadjuvant regime of JS001+XELOX or SOX. XELOX: 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 4 cycles, adjuvant chemotherapy for 4 cycles.
Receives: Drug: JS001+XELOX or SOX

What is being measured

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

  1. Major pathologic response (MPR)

    It is defined as residual tumors less than 10% after neoadjuvant immunotherapy and(or) chemotherapy

    Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 14 weeks

Secondary outcomes (5)

  1. Disease-free survival (DFS)

    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

  2. Overall survival(OS)

    Measured: From date of randomization until the date of first documented date of death from any cause, assessed up to 36 months

  3. pCR

    Pathological complete response after neoadjuvant immunotherapy and(or) chemotherapy

    Measured: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 14 weeks

  4. 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 14 weeks

  5. Adverse event incidence rate

    Number of participants with treatment-related adverse events as assessed by National Cancer Institute-Common Terminology Criteria for Adverse Events [NCI-CTCAE] v4.03

    Measured: Patients will be assessed for adverse events throughout the study at every visit during treatment and at 3-month follow-up visit (3 months after treatment ends)

Timeline

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

  1. First posted9 Feb 2021
  2. Study start12 Mar 2021
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 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
Double blind
Who is masked
Care provider, Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04744649
Sponsor's protocol ID
NICE
Acronym
NICE
Status last verified
Nov 2022
First submitted
23 Jan 2021
Last updated
15 Nov 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: We will share Study Protocol and Statistical Analysis Plan (SAP)

Publications

  • Zhao L, Liu H, Yu J, Yuan S, Liang H, Wang W, Jiang J, Yu L, Liang L, Chen Z, Chen X, Zhong X, Zheng Y, Li F, Lin T, Zhao M, Chen T, Chen H, Hu Y, Li G. Efficacy and safety of neoadjuvant toripalimab plus chemotherapy in localized deficient mismatch repair/microsatellite instability-high gastric or esophagogastric junction adenocarcinoma (NICE): a multicentre, single-arm, exploratory phase 2 study. EClinicalMedicine. 2025 Aug 12;87:103421. doi: 10.1016/j.eclinm.2025.103421. eCollection 2025 Sep.

    PubMed 40838201

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing XELOX or SOX and JS001+XELOX or SOX in people with Gastric Cancer and Stomach Neoplasm, run by Nanfang Hospital, Southern Medical University at 10 sites 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 19 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 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites 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?

Contact Guoxin Li, M.D., Ph.D. (+86 13802771450, gzliguoxin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major pathologic response (MPR) (time frame: From the initiation date of first cycle (each cycle is 21 days) to the date of operation, an average of 14 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 NCT04744649, 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 Nov 2022.

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