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Gastric (Stomach) CancerEarly Phase 1FUGES032NCT07356466

Clinical Efficacy of Pucotenlimab Combined With Lenvatinib and SOX Versus SOX Alone in Patients With HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma

A Early Phase 1 study testing Pucotenlimab Combined with Lenvatinib and Oxaliplatin plus S-1 regimen in people with Gastric (Stomach) Cancer, run by Fujian Medical University at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the objective response rate (ORR) of Pembrolizumab combined with Lenvatinib and SOX compared with SOX alone in the treatment of patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Gastric (Stomach) Cancer
What is being tested?
Pucotenlimab Combined with Lenvatinib and Oxaliplatin plus S-1 regimen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 May 2025to 30 Apr 2030
Phase
Early Phase 1
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

  • Inclusion Criteria 1. Age 18-75 years (inclusive). 2. Histologically or cytologically confirmed unresectable, locally advanced or metastatic HER2-negative adenocarcinoma of the stomach or gastro-oesophageal junction (GEJ).
  • 3. No prior systemic chemotherapy, radiotherapy, targeted therapy, or immunotherapy for advanced disease. Subjects who have received prior (neo)adjuvant chemotherapy and/or radiotherapy are eligible provided the last dose was completed ≥ 6 months before randomisation.
  • 4. At least one measurable lesion per RECIST 1.1 (see Appendix 2). 5. Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 (see Appendix 4).
  • 6. Estimated life expectancy > 3 months. 7. Adequate major organ function defined as:
  • Haematology (obtained ≤ 14 days without transfusion):
  • Hb ≥ 80 g/L
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  • WBC ≥ 3 × 10⁹/L
  • ANC ≥ 1.5 × 10⁹/L
  • PLT ≥ 100 × 10⁹/L
  • Biochemistry:
  • Total bilirubin < 1.5 × upper limit of normal (ULN)
  • ALT and AST < 2.5 × ULN; ALP ≤ 1.5 × ULN
  • Serum creatinine ≤ 1 × ULN and calculated creatinine clearance ≥ 60 mL/min (Cockcroft-Gault formula) 8. Women of child-bearing potential must have a negative serum pregnancy test within 7 days prior to enrolment and must use highly effective contraception from screening until 8 weeks after the last dose of study drug. Men must be surgically sterile or agree to use effective contraception during the same period.
  • 9. No participation in any other interventional clinical trial during the pre-treatment or on-treatment phases of this study.
  • 10. Voluntary written informed consent obtained; willing and able to comply with study procedures and follow-up.

Who cannot join

  • Subjects meeting any of the following conditions will be excluded from enrollment:
  • Known or suspected hypersensitivity to the investigational drug or any drug of the same class.
  • Other malignancies within the past 5 years, except adequately treated basal-cell or squamous-cell carcinoma of the skin or carcinoma in situ of the cervix.
  • Currently receiving treatment in another interventional clinical trial, or any systemic anti-gastric-cancer therapy within 4 weeks prior to the first dose.
  • Systemic Chinese patent medicines with anti-tumor indications or immunomodulatory agents (e.g., thymosin, interferon, interleukins; local intrapleural use for effusion control is permitted) received within 2 weeks before the first dose.
  • Prior exposure to: anti-PD-1, anti-PD-L1, anti-PD-L2, or any agent targeting other T-cell co-stimulatory or co-inhibitory pathways (including but not limited to CTLA-4, OX-40, CD137); or prior chemotherapy including S-1.
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  • Live-vaccine administration within 4 weeks before enrollment or planned during the study.
  • Note: Inactivated seasonal influenza vaccine by injection is allowed within 4 weeks; intranasal live-attenuated influenza vaccine is prohibited.
  • Active autoimmune disease requiring systemic therapy (e.g., immunosuppressants, corticosteroids, or disease-modifying agents) within 2 years before the first dose. Replacement therapy (thyroxine, insulin, physiologic glucocorticoids for adrenal or pituitary insufficiency) is not considered systemic therapy.
  • Prior allogeneic bone-marrow or solid-organ transplantation.
  • Any condition that could impair drug absorption or inability to swallow oral medication.
  • Uncontrolled hypertension despite optimal medical management:
  • SBP ≥ 150 mmHg or DBP ≥ 100 mmHg on a single antihypertensive, or requirement of ≥ 2 antihypertensive agents.
  • Urinalysis showing proteinuria ≥ 2+ and 24-h urinary protein > 1.0 g.
  • Active gastro-duodenal ulcer, ulcerative colitis, or other gastrointestinal disorders with bleeding risk; un-resected tumors with active hemorrhage; or any other condition judged by the investigator to predispose to GI bleeding or perforation.
  • Significant bleeding tendency within 3 months before enrollment: overt bleeding > 30 mL, hematemesis, melena, hematochezia; hemoptysis (> 5 mL fresh blood within 4 weeks); or thrombo-embolic event (including stroke/TIA) within 12 months.
  • Clinically significant cardiovascular disease:
  • Acute MI, unstable/severe angina, or CABG within 6 months before enrollment;
  • NYHA class > II congestive heart failure;
  • Ventricular arrhythmia requiring therapy;
  • QTc ≥ 480 ms on baseline ECG.
  • Active or uncontrolled severe infection (≥ CTCAE grade 2).
  • Known HIV infection; clinically significant hepatic disorders:
  • Chronic hepatitis B with active replication (HBV DNA > 1 × 10⁴ copies/mL or > 2000 IU/mL);
  • Hepatitis C with detectable HCV RNA (> 1 × 10³ copies/mL);
  • Other hepatitis or cirrhosis.
  • Known dihydropyrimidine dehydrogenase (DPD) deficiency.
  • Any condition that, in the opinion of the investigator, would compromise the subject's safety or interfere with study participation.

Trial locations and contacts

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

China1 site

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

Other trials in China

About this study

Official title: Clinical Efficacy of Pucotenlimab Combined With Lenvatinib and SOX Versus SOX Alone in Patients With HER2-Negative Advanced Gastric or Gastroesophageal Junction Adenocarcinoma: A Single-Center Randomized Controlled Trial

The purpose of this study is to evaluate the objective response rate (ORR) of Pembrolizumab combined with Lenvatinib and SOX compared with SOX alone in the treatment of patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma.

Read the detailed description

At present, for patients with advanced gastric cancer, palliative chemotherapy or the best supportive care is the main treatment approach, but the therapeutic effect is not satisfactory. The median survival time is around 10-16 months, and the survival rate of patients is very low. How to improve the treatment effect of advanced gastric cancer is an urgent problem to be solved. Currently, several studies on immunotherapy combined with chemotherapy for gastric cancer are underway. From the subgroup analyses of a series of studies ，it can be seen that the expression of PDL1 is increased, which provides a basis for the treatment of advanced tumors with immune checkpoint inhibitors. Studies have shown that the combination of Lenvatinib can reduce angiogenesis in mice, reprogram vascular structure, enhance the infiltration of CD8+ T cells, CD8+ TNFα+ T cells and CD8+ IFNγ+ T cells, and decrease the proportion of MDSCs and macrophages. This provides a basis for the combined use of Lenvatinib and immune checkpoint inhibitors in the treatment of advanced tumors. This study adopts a single-center, prospective research method, aiming to explore the clinical effectiveness and safety of Pucotenlimab combined with Lenvatinib and the SOX regimen in the treatment of patients with HER2-negative advanced gastric or gastroesophageal junction adenocarcinoma.

Being tested
Pucotenlimab Combined with Lenvatinib, Oxaliplatin plus S-1 regimen
Keywords
Gastric Cancer, HER2-Negative, Objective response rate
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Pucotenlimab Combined with LenvatinibDrug

    Pucotenlimab Combined with Lenvatinib

  • Oxaliplatin plus S-1 regimenDrug

    Oxaliplatin plus S-1 regimen

Study groups in NCT07356466
Study groupRoleWhat they receive
Research GroupExperimentalParticipants receive Study Drug Pucotenlimab Combined with Lenvatinib and SOX .
Receives: Drug: Pucotenlimab Combined with Lenvatinib
Control GroupOtherOxaliplatin plus S-1 regimen
Receives: Drug: Oxaliplatin plus S-1 regimen

What is being measured

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

  1. Objective response rate

    Objective Response Rate (ORR) is defined as the proportion of patients with confirmed complete response (CR) or partial response (PR) based on standardized, objective criteria (e.g., RECIST 1.1).

    Measured: 30day

  2. Objective Response Rate

    This study uses the objective response rate (ORR) as the primary efficacy evaluation metric.

    Measured: 30day

Secondary outcomes (6)

  1. Median Overall Survival

    Median Overall Survival (OS) is defined as the time from the date of diagnosis or initiation of treatment to the point at which 50% of patients have died (or reached the study endpoint event), serving as a key indicator for evaluating treatment efficacy and prognosis in chronic diseases such as cancer.

    Measured: according to the OS

  2. Progression-Free Survival

    Progression-Free Survival (PFS) is defined as the time from randomization (or initiation of treatment) to the first documented disease progression (PD) or death from any cause, whichever occurs first

    Measured: 36 months

  3. Duration of Response

    Duration of Response (DOR) is defined as the time from the first documented complete response (CR) or partial response (PR) until disease progression (PD) or death from any cause, whichever occurs first.

    Measured: 30day

  4. Adverse Event

    Adverse Event (AE) Incidence Rate is defined as the proportion of participants in a defined analysis set who experience at least one adverse event during a specified observation period after initiation of an intervention (drug, device, or procedure); it quantifies the frequency of intervention-related risk.

    Measured: 30 days

  5. Serious Adverse Event

    erious Adverse Event (SAE) Incidence Rate is defined as the proportion of participants in a defined analysis set who experience at least one adverse event meeting seriousness criteria during a specified observation period after initiation of an intervention; it quantifies intervention-related risks with potential for major medical consequences or death.

    Measured: 30 days

  6. Quality of Life (QoL) assessment

    Quality of Life (QoL) assessment is the systematic collection of patients' subjective experience across multiple domains-including physical function, psychological state, social adaptation, and symptom burden-using validated, standardized patient-reported outcome (PRO) instruments; it quantifies the overall impact of disease and its treatment on patients' daily living and serves as a key endpoint in clinical research and therapeutic decision-making.

    Measured: 36 months

Timeline

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

  1. First posted21 Jan 2026
  2. Study start1 May 2025
  3. Primary completion30 Apr 2027 (estimated)
  4. Study completion30 Apr 2030 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07356466
Sponsor's protocol ID
FUGES032
Acronym
FUGES032
Status last verified
Oct 2025
First submitted
21 Dec 2025
Last updated
21 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Heinrich MC, Jones RL, von Mehren M, Schoffski P, Serrano C, Kang YK, Cassier PA, Mir O, Eskens F, Tap WD, Rutkowski P, Chawla SP, Trent J, Tugnait M, Evans EK, Lauz T, Zhou T, Roche M, Wolf BB, Bauer S, George S. Avapritinib in advanced PDGFRA D842V-mutant gastrointestinal stromal tumour (NAVIGATOR): a multicentre, open-label, phase 1 trial. Lancet Oncol. 2020 Jul;21(7):935-946. doi: 10.1016/S1470-2045(20)30269-2.

    PubMed 32615108

  • Tang X, Yang J, Shi A, Xiong Y, Wen M, Luo Z, Tian H, Zheng K, Liu Y, Shu C, Ma N, Wang R, Zhao J. CD155 Cooperates with PD-1/PD-L1 to Promote Proliferation of Esophageal Squamous Cancer Cells via PI3K/Akt and MAPK Signaling Pathways. Cancers (Basel). 2022 Nov 15;14(22):5610. doi: 10.3390/cancers14225610.

    PubMed 36428703

  • Lai X, Gupta SK, Schmitz U, Marquardt S, Knoll S, Spitschak A, Wolkenhauer O, Putzer BM, Vera J. MiR-205-5p and miR-342-3p cooperate in the repression of the E2F1 transcription factor in the context of anticancer chemotherapy resistance. Theranostics. 2018 Jan 1;8(4):1106-1120. doi: 10.7150/thno.19904. eCollection 2018.

    PubMed 29464002

  • Furtado J. Decentralising HIV treatment in lower- and middle-income countries. Sao Paulo Med J. 2014 Dec;132(6):383. doi: 10.1590/1516-3180.20141326t2.

    PubMed 25351762

  • Wang W, Kirsch T. Annexin V/beta5 integrin interactions regulate apoptosis of growth plate chondrocytes. J Biol Chem. 2006 Oct 13;281(41):30848-56. doi: 10.1074/jbc.M605937200. Epub 2006 Aug 16.

    PubMed 16914549

  • Goser S, Ottl R, Brodner A, Dengler TJ, Torzewski J, Egashira K, Rose NR, Katus HA, Kaya Z. Critical role for monocyte chemoattractant protein-1 and macrophage inflammatory protein-1alpha in induction of experimental autoimmune myocarditis and effective anti-monocyte chemoattractant protein-1 gene therapy. Circulation. 2005 Nov 29;112(22):3400-7. doi: 10.1161/CIRCULATIONAHA.105.572396.

    PubMed 16316965

  • Paulus BC, Adelman SL, Jamula LL, McCusker JK. Leveraging excited-state coherence for synthetic control of ultrafast dynamics. Nature. 2020 Jun;582(7811):214-218. doi: 10.1038/s41586-020-2353-2. Epub 2020 Jun 11.

    PubMed 32528090

  • Hasson A, Jiang W, Benabdallah N, Lu P, Longtine MS, Beattie BJ, Summer L, Zhang H, Wahl RL, Abou DS, Thorek DLJ. Radiochemical Quality Control Methods for Radium-223 and Thorium-227 Radiotherapies. Cancer Biother Radiopharm. 2023 Feb;38(1):15-25. doi: 10.1089/cbr.2022.0023. Epub 2022 Sep 23.

    PubMed 36149725

  • Walczak-Sztulpa J, Wawrocka A, Doornbos C, van Beek R, Sowinska-Seidler A, Jamsheer A, Bukowska-Olech E, Latos-Bielenska A, Grenda R, Bongers EMHF, Schmidts M, Obersztyn E, Krawczynski MR, Oud MM. Identical IFT140 Variants Cause Variable Skeletal Ciliopathy Phenotypes-Challenges for the Accurate Diagnosis. Front Genet. 2022 Jul 7;13:931822. doi: 10.3389/fgene.2022.931822. eCollection 2022.

    PubMed 35873489

  • Zhu YZ, Zhong JX, Dong LL. Menstrual and Reproductive Characteristics of Patients with Primary Sjogren's Syndrome: A 7-year Single-center Retrospective Study. Curr Med Sci. 2023 Feb;43(1):139-145. doi: 10.1007/s11596-022-2675-4. Epub 2022 Dec 21.

    PubMed 36542325

  • Monga J, Adrianto I, Rogers C, Gadgeel S, Chitale D, Alumkal JJ, Beltran H, Zoubeidi A, Ghosh J. Tribbles 2 pseudokinase confers enzalutamide resistance in prostate cancer by promoting lineage plasticity. J Biol Chem. 2022 Feb;298(2):101556. doi: 10.1016/j.jbc.2021.101556. Epub 2021 Dec 30.

    PubMed 34973338

  • Bhowmick T, Liu C, Imp B, Sharma R, Boruchoff SE. Ceftaroline as salvage therapy for complicated MRSA bacteremia: case series and analysis. Infection. 2019 Aug;47(4):629-635. doi: 10.1007/s15010-019-01304-7. Epub 2019 Apr 6.

    PubMed 30955166

  • Wang SM, Han C, Lee SJ, Jun TY, Patkar AA, Masand PS, Pae CU. Investigational dopamine antagonists for the treatment of schizophrenia. Expert Opin Investig Drugs. 2017 Jun;26(6):687-698. doi: 10.1080/13543784.2017.1323870. Epub 2017 May 12.

    PubMed 28443355

  • Zhang MZ, Yao B, Wang S, Fan X, Wu G, Yang H, Yin H, Yang S, Harris RC. Intrarenal dopamine deficiency leads to hypertension and decreased longevity in mice. J Clin Invest. 2011 Jul;121(7):2845-54. doi: 10.1172/JCI57324. Epub 2011 Jun 23.

    PubMed 21701066

  • Craig A, Kool J, Nilles E. The Pacific experience: supporting small island countries and territories to meet their 2012 International Health Regulations (2005) commitments. Western Pac Surveill Response J. 2013 Jul 3;4(3):14-8. doi: 10.5365/WPSAR.2012.3.4.007. eCollection 2013 Jul-Sep.

    PubMed 24319608

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Pucotenlimab Combined with Lenvatinib and Oxaliplatin plus S-1 regimen in people with Gastric (Stomach) Cancer, run by Fujian Medical 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 15 inclusion and 28 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: enrolling by invitation, as of the sponsor's last update on 21 Jan 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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?

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?

Objective response rate (time frame: 30day). 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 NCT07356466, which also lists 21 linked publications.

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 21 Jan 2026.

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