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Gastric CancerPhase 2NCT06461910

Efficacy and Safety of Anti-PD-1, Thymalfasin, and SOX in Neoadjuvant Treatment of cStage III Gastric/Gastroesophageal Junction Adenocarcinoma

A Phase 2 study testing Serplulimab, thymalfasin and Oxaliplatin in people with Gastric Cancer and Esophagogastric Junction Adenocarcinoma, run by Zekuan Xu at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal… Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Serplulimab, thymalfasin and Oxaliplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
14 Jun 2024to Dec 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 and Diagnosis:
  • Patients aged 18-75 years with gastric (G) or gastroesophageal junction (GEJ) adenocarcinoma, regardless of gender.
  • Stage and Diagnosis Confirmation:
  • According to the 8th edition of AJCC staging for gastric cancer, patients must be assessed via abdominal CT as cStage III (cT3-4aN1-3M0).
  • Diagnosis must be confirmed by endoscopy and pathology as G/GEJ adenocarcinoma (HER-2 negative).
  • Only patients with Siewert type III and type II (who do not require combined thoracic surgery) GEJ cancer are eligible.
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  • Surgical Assessment:
  • Tumors must be deemed resectable with curative intent (R0 resection) as determined by a gastrointestinal surgeon and a radiologist.
  • Patients must agree to undergo radical surgery and be deemed operable by a surgeon.
  • Previous Treatments:
  • Patients must not have received prior systemic treatment for the current disease, including surgery, anti-tumor chemotherapy, radiotherapy, or immunotherapy.
  • Survival Expectancy:
  • Expected survival of at least 3 months.
  • Measurable Disease:
  • Tumors must be measurable according to RECIST v1.1 criteria.
  • Performance Status:
  • ECOG PS score of 0-1 within 7 days prior to the first dose.
  • Cardiac Function:
  • Good cardiac function, suitable for curative surgery. Preoperative evaluation by a cardiologist is required if there are clinical indications of underlying ischemic, valvular, or other severe heart diseases.
  • Organ Function:
  • Normal function of major organs, meeting the following laboratory criteria:
  • Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L without granulocyte colony-stimulating factor for the past 14 days.
  • Platelet count ≥ 100 x 10^9/L without transfusion for the past 14 days. Hemoglobin > 9 g/dL without transfusion or erythropoietin use for the past 14 days.
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN); if > 1.5 x ULN, direct bilirubin must be ≤ ULN.
  • AST and ALT ≤ 2.5 x ULN. Serum creatinine ≤ 1.5 x ULN and creatinine clearance (using Cockcroft-Gault formula) ≥ 60 ml/min.
  • Normal coagulation function (INR or PT ≤ 1.5 x ULN). Normal thyroid function (TSH within normal range, or normal T3/FT3 and FT4 if baseline TSH is out of range).
  • Normal myocardial enzyme spectrum (clinical judgment for non-significant lab abnormalities is acceptable).
  • Weight:
  • Body weight ≥ 40 kg or BMI > 18.5.
  • Female Patients:
  • Must be post-menopausal (no menses for at least one year without other causes) or surgically sterilized (removal of ovaries and/or uterus).
  • Women of childbearing potential must have a negative pregnancy test within 7 days prior to the first dose.
  • Agree to use highly effective contraception (annual failure rate < 1%) or abstain from heterosexual intercourse from the time of informed consent until at least 120 days after the last dose of the study drug or 9 months after surgery.
  • Male Patients:
  • Must agree to use contraception or abstain from heterosexual intercourse from the time of informed consent until at least 120 days after the last dose of the study drug or 9 months after surgery.
  • Regular abstinence (e.g., calendar, ovulation, basal body temperature, or post-ovulation methods) and withdrawal are not acceptable forms of contraception.
  • Informed Consent:
  • Patients must read, understand, and sign the informed consent form.

Who cannot join

  • Other Malignancies:
  • Patients with a history of other malignancies within the past 5 years or concurrent malignancies. Exceptions include cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, in situ prostate cancer, in situ cervical cancer, in situ breast cancer, stage I lung cancer, and stage I colorectal cancer.
  • Transplant Patients:
  • Patients planning to undergo or having previously undergone organ or bone marrow transplantation.
  • Blood Transfusions and Bleeding:
  • Patients who have received a blood transfusion within 2 weeks before the first dose, have a history of bleeding, or experienced any severe bleeding events (grade 3 or higher per CTCAE 4.0) within 4 weeks before screening.
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  • Coagulation Disorders:
  • Patients with coagulation abnormalities and bleeding tendencies (INR > 1.5 without anticoagulants). Patients on anticoagulants or vitamin K antagonists like warfarin, heparin, or similar drugs can participate if INR ≤ 1.5, small-dose warfarin (1 mg/day) or aspirin (≤ 100 mg/day) is allowed for preventive use.
  • Thromboembolic Events:
  • Patients with arterial/venous thromboembolic events within 6 months before screening, such as stroke (including transient ischemic attacks), deep vein thrombosis (excluding cases resolved post-chemotherapy), and pulmonary embolism.
  • Cardiac Conditions:
  • Patients with myocardial infarction, uncontrolled arrhythmias (including QTc interval ≥ 450 ms for males and ≥ 470 ms for females, using the Fridericia formula) within 6 months before the first dose.
  • NYHA class III-IV heart failure or LVEF < 50% on echocardiogram.
  • Proteinuria:
  • Urinalysis indicating proteinuria ≥ ++ and 24-hour urine protein > 1.0 g.
  • Oral Drug Absorption Issues:
  • Factors affecting oral drug absorption (e.g., inability to swallow, chronic diarrhea, bowel obstruction).
  • Pleural or Peritoneal Effusion:
  • Clinically significant pleural or peritoneal effusion requiring intervention.
  • HIV Infection:
  • Patients with HIV infection.
  • Active Tuberculosis:
  • Patients with active tuberculosis.
  • Non-Healing Wounds or Fractures:
  • Patients with long-standing unhealed wounds or incomplete healing of fractures.
  • Lung Diseases:
  • Patients with interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonitis, or severely impaired lung function that could interfere with the detection and treatment of suspected drug-related pulmonary toxicity.
  • Autoimmune Diseases:
  • Patients with known active or suspected autoimmune diseases, except those in a stable state without systemic immunosuppressive treatment.
  • Chronic Autoimmune Diseases:
  • Severe chronic autoimmune diseases such as systemic lupus erythematosus; patients with a history of ulcerative colitis, Crohn's disease, or irritable bowel syndrome; history of sarcoidosis or tuberculosis; active hepatitis B or C, and HIV infection.
  • Well-controlled non-severe autoimmune diseases like dermatitis, arthritis, psoriasis can be included. Patients with hepatitis B virus titers < 500 copies/ml can participate.
  • Immunosuppressive Treatment:
  • Patients requiring systemic corticosteroids (> 10 mg/day prednisone equivalent) or other immunosuppressive drugs within 14 days before the first dose or during the study. Localized topical or inhaled steroids or adrenal hormone replacement therapy (≤ 10 mg/day prednisone equivalent) are allowed.
  • Active Infections:
  • Active infections requiring systemic treatment within 14 days before the first dose. Preventive antibiotic treatment (e.g., for urinary tract infection or COPD) is allowed.
  • Live Vaccines:
  • Patients who have received live vaccines within 28 days before the first dose. Inactivated viral vaccines for seasonal flu are allowed.
  • Previous Checkpoint Inhibitors:
  • Patients previously treated with checkpoint inhibitors like PD-1, PD-L1, or CTLA-4 inhibitors.
  • Immunomodulatory Treatments:
  • Patients who received immunomodulatory treatments (e.g., thymopentin, thymalfasin, interferons, CAR-T therapy) within 6 months before the first dose.
  • Other Clinical Studies:
  • Patients currently receiving other clinical study treatments or planning to start this study treatment within one month of completing a previous clinical study treatment.
  • Drug Allergies:
  • Known allergy or intolerance to any study drug or its components.
  • Substance Abuse:
  • History of alcohol, drug, or substance abuse. Patients who have stopped drinking can be included.
  • Compliance Issues:
  • Patients who are non-compliant with medical instructions, prescribed medications, or have incomplete records affecting efficacy or safety assessments.
  • Pregnancy and Breastfeeding:
  • Pregnant or breastfeeding women.
  • High-Risk Factors:
  • Patients with conditions increasing the risk of study participation or study drug use, or other severe, acute, or chronic diseases deemed unsuitable by the investigator.
  • Investigator Discretion:
  • Any other conditions that the investigator deems unsuitable for the clinical trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Hao Xu, MD contact

+86 13851530117

hxu@njmu.edu.cn

Hongda Liu, MD contact

+86 17521597055

Liuhongda@njmu.edu.cn

China1 site, 1 recruiting

  • The First Hospital of Nanjing Medical University

    Nanjing, Jiangsu

    Hongda Liu, +86 17521597055, Liuhongda@njmu.edu.cn

    Hao Xu, MD

    Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of Anti-PD-1 Combined With Thymalfasin and SOX in Neoadjuvant Treatment of cStage III Gastric or Gastroesophageal Junction Adenocarcinoma: A Prospective, Open-label, Single-arm, Phase II Clinical Study

This Phase II clinical study is a prospective, open-label, single-arm trial designed to evaluate the efficacy and safety of combining anti-PD-1 therapy (Serplulimab) with thymalfasin and the SOX chemotherapy regimen as a neoadjuvant treatment for patients with clinical stage III gastric or gastroesophageal junction(GEJ) adenocarcinoma.

Read the detailed description

This is a prospective, open-label, single-arm phase II clinical study to assess the efficacy and safety of Serplulimab in combination with thymalfasin and SOX regimen for neoadjuvant therapy of locally advanced gastric cancer. It is planned to enroll 30 patients with HER2-negative gastric or gastroesophageal junction adenocarcinoma confirmed by histopathology and/or cytology who were clinically staged as stage III resectable G/GEJ carcinoma as assessed by endoscopic ultrasonography, CT/MRI and other imaging. The primary endpoint of the study was pathological complete response (pCR) rate. The secondary end points included major pathological response(MPR) rate, Tumor Regression Grade (TRG), Clinical downstaging rate (T and/or N downstaging), Objective Response Rate (ORR), Disease Control Rate (DCR), R0 resection rate, Disease-free Survival (DFS), Overall Survival (OS) and treatment-related adverse events (TRAEs).

Being tested
Serplulimab, thymalfasin, Oxaliplatin, Tegafur
Keywords
neoadjuvant, PD-1, Thymalfasin, Chemotherapy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • SerplulimabDrug

    300 mg, i.v., D1, Q3W

  • thymalfasinDrug

    4.8mg,sc,biw

  • OxaliplatinDrug

    130 mg/m2, i.v., D1, Q3W

  • TegafurDrug

    oral administration: body surface area < 1.25, 40 mg each time; body surface area ≥ 1.25 to < 1.5, 50 mg each time; body surface area ≥ 1.5, 60 mg each time, twice daily for each treatment cycle at D1-D14

Study groups in NCT06461910
Study groupRoleWhat they receive
Serplulimab Combined with Thymalfasin and SOXExperimentalNot described
Receives: Drug: Serplulimab; Drug: thymalfasin; Drug: Oxaliplatin; Drug: Tegafur

What is being measured

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

  1. pathological Complete Response (pCR)

    pCR was defined as no residual tumor cells on the histologic examination of surgical specimens.

    Measured: from preoperative to 10 days postoperative

Secondary outcomes (9)

  1. Major Pathological Response (MPR)

    For patients with surgically resectable gastric cancer after neoadjuvant therapy, the proportion of patients with less than 10% residual tumor cells in the primary site.

    Measured: from preoperative to 10 days postoperative

  2. Tumor Regression Grade (TRG)

    It is intended to grade the pathological response of tumor after neoadjuvant therapy and generally divide the grade mainly according to the proportion of fibrosis and residual tumor in the tumor. In this study, Becker criteria are used to grade TGR as follows: TRG1a (no residual tumor), equivalent to pCR; TRG1b (< 10% residual tumor); TRG2 (10% to 50% residual tumor); and TRG3 (> 50% residual tumor).

    Measured: from preoperative to 10 days postoperative

  3. Clinical downstaging rate (T and/or N downstaging)

    ypT0 ratio, ypN0 ratio, and preoperative imaging clinical stage will be counted, respectively, to compare with baseline imaging clinical stage downstaging ratio

    Measured: before surgery

  4. Objective Response Rate (ORR)

    It refers to the proportion of patients whose tumor shrinks to a certain extent and remains for a certain period of time, including CR (Complete Response) and PR (Partial Response) cases. Objective tumor response will be assessed using Response Evaluation Criteria in Solid Tumors (RECIST 1.1 criteria).

    Measured: before surgery

  5. Disease Control Rate (DCR)

    It refers to the percentage of confirmed complete response (CR), partial response (PR) and stable disease (SD) cases among evaluable efficacy patients.

    Measured: before surgery

  6. Disease-free Survival (DFS)

    Disease-free survival refers to the time from the start of randomization to disease recurrence or death due to disease progression. DFS will be defined as the last date the patient is last confirmed to be disease-free survival if the patient does not experience disease progression during the study.

    Measured: 2 years after surgery

  7. Overall Survival (OS)

    Overall survival refers to the date from enrollment to death due to any cause.

    Measured: 2 years after surgery

  8. R0 resection rate

    R0 resection rate refers to the proportion of patients who complete R0 resection in surgically resectable patients after neoadjuvant therapy.

    Measured: from preoperative to 10 days postoperative

  9. treatment-related adverse event (TRAE)

    incidence of treatment-related adverse event

    Measured: from the start of neoadjuvant therapy to 30 days after surgery

Timeline

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

  1. First posted17 Jun 2024
  2. Study start14 Jun 2024
  3. Primary completion28 Jan 2026
  4. Study completionDec 2027 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06461910
Sponsor's protocol ID
GATES
Status last verified
Feb 2026
First submitted
12 Jun 2024
Last updated
3 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Export of individual patient data is a sensitive issue according to current Chinese laws.

Publications

  • Xu H, Li F, Li B, Yang D, Liu T, Xia Y, Hua H, Li Q, Wang J, Liu H, Xu Z. Neoadjuvant immunochemotherapy plus thymalfasin in locally advanced gastric cancer: a prospective clinical trial. BMC Med. 2026 Feb 26;24(1):143. doi: 10.1186/s12916-026-04740-z.

    PubMed 41749205

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Serplulimab, thymalfasin and Oxaliplatin in people with Gastric Cancer and Esophagogastric Junction Adenocarcinoma, run by Zekuan Xu 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 38 inclusion and 56 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Hao Xu, MD (+86 13851530117, hxu@njmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

pathological Complete Response (pCR) (time frame: from preoperative to 10 days postoperative). 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 NCT06461910, 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 3 Mar 2026.

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