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Advanced Gastric or Gastroesophageal Junction (G/GEJ) AdenocarcinomaPhase 2NCT06939452

A Single-arm, Multicenter Exploratory Clinical Trial of Anlotinib Combined With TQB2450 and the SOX Regimen as First-line Treatment for Advanced Gastric Cancer With Low PD-L1 Expression

A Phase 2 study testing anlotinib +TQB2450 + Oxaliplatin+S-1 in people with Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma, run by Yongxu Jia at 1 site in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

To evaluate the efficacy and safety of anlotinib combined with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
anlotinib +TQB2450 + Oxaliplatin+S-1
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
1 siteChina
Study dates
7 Jun 2023to 1 Jun 2026
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Willing and able to provide written informed consent and comply with study procedures.
  • 2. Histologically or cytologically confirmed HER2-negative (or HER2 status undetermined) unresectable locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (including signet ring cell carcinoma, mucinous adenocarcinoma, and hepatoid adenocarcinoma variants).
  • 3. Disease recurrence >6 months after completion of (neo)adjuvant chemotherapy or radiotherapy.
  • 4. At least one measurable or evaluable lesion according to RECIST v1.1 criteria. Measurable lesions must not have received prior local therapy (e.g., radiotherapy); however, lesions within previously irradiated fields may be designated as target lesions if documented progression is demonstrated per RECIST v1.1.
  • 5. Age 18 and above.
  • 6. ECOG performance status 0-1.
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  • 7. Life expectancy ≥3 months.
  • 8. Organ Function Requirements and Laboratory Test Criteria During Screening (1) Complete Blood Count (CBC) Criteria： Hemoglobin (Hb): ≥ 90 g/L (no blood transfusion within 14 days) Absolute Neutrophil Count (ANC): ≥ 1.5 × 10⁹/L Platelet Count (PLT): ≥ 100 × 10⁹/L (no use of interleukin-11 [IL-11] or thrombopoietin [TPO] within 14 days) White Blood Cell Count (WBC): ≥ 4.0 × 10⁹/L (no granulocyte colony-stimulating factor [G-CSF] administration within 14 days) (2) Biochemical Panel Requirements: Total Bilirubin (TBIL): ≤ 1.5 × ULN (upper limit of normal),Alanine Aminotransferase (ALT) \& Aspartate Aminotransferase (AST): ≤ 2.5 × ULN,Serum Creatinine (Cr): ≤ 1.5 × ULN or Creatinine Clearance (CrCl): ≥ 60 mL/min (calculated by Cockcroft-Gault formula),Serum Albumin: ≥ 25 g/L (2.5 g/dL) For Subjects with Hepatic Metastases:Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT): ≤ 5 × ULN，White Blood Cell Count (WBC): ≥ 4 × 10⁹/L，Platelet Count (PLT): ≥ 100 × 10⁹/L (without transfusion support)， Absolute Neutrophil Count (ANC): ≥ 1.5 × 10⁹/L (without granulocyte colony-stimulating factor [G-CSF] therapy) (3) Cardiac Function Assessment (Echocardiography)：Left Ventricular Ejection Fraction (LVEF): ≥ 50% (or above institutional lower limit of normal) (4) Coagulation Profile：International Normalized Ratio (INR) or Prothrombin Time (PT): ≤ 1.5 × ULN
  • 9. Women of reproductive age must use effective contraception during the study period, after the last dose, and for at least 6 months following chemotherapy. It is recommended to start using contraception at least 3 months before the administration of the investigational drug; unsterilized males must also be required to use effective contraception for at least 6 months during the study period, after the last dose, and following chemotherapy. It is recommended to start using contraception at least 3 months before the administration of the investigational drug.
  • 10. PD-L1 combined positive score ( CPS) <5

Who cannot join

  • 1. Prior treatment with anlotinib hydrochloride or any immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies);
  • 2. History of immunodeficiency disorders, including HIV infection, other acquired or congenital immunodeficiency diseases, or prior organ transplantation;
  • 3. Active hepatitis B or C infection, or active pulmonary tuberculosis;
  • 4. CT-confirmed ulcerative lesions or fecal occult blood positivity;
  • 5. History of clinically significant bleeding (excluding epistaxis) within 1 month prior to enrollment;
  • 6. Previous allogeneic bone marrow or solid organ transplantation;
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  • 7. Interstitial lung disease including idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or CT-confirmed active pneumonia;
  • 8. Administration of live attenuated vaccines within 4 weeks before study initiation or anticipated during the study through 5 months post-treatment;
  • 9. Systemic corticosteroids (>10 mg/day prednisone equivalent) or immunosuppressive therapy within 2 weeks prior to study initiation (inhaled or topical corticosteroids are permitted);
  • 10. Known symptomatic CNS metastases or leptomeningeal carcinomatosis. Patients with previously treated CNS metastases may be eligible if neurologically stable for ≥4 weeks without steroids or anticonvulsants;
  • 11. Conditions impairing oral drug absorption (e.g., dysphagia, chronic diarrhea, or intestinal obstruction);
  • 12. Grade ≥2 peripheral neuropathy per NCI CTCAE v5.0;
  • 13. Active infections requiring systemic antibiotics within 14 days prior to study entry;
  • 14. Hepatic tumor burden exceeding 50% of total liver volume;
  • 15. Bone metastases with impending spinal cord compression risk;
  • 16. Uncontrolled comorbidities including:
  • Poorly controlled hypertension (SBP ≥150 mmHg or DBP ≥100 mmHg despite antihypertensives)
  • Grade ≥2 myocardial ischemia, myocardial infarction, or arrhythmias (QTc ≥480 ms)
  • NYHA Class III-IV heart failure or LVEF <50% by echocardiography
  • Uncontrolled active infections
  • Decompensated liver cirrhosis or active hepatitis
  • Uncontrolled diabetes (FBG >10 mmol/L)
  • Proteinuria ≥++ on dipstick or confirmed 24-hour urinary protein >1.0 g
  • 17. Non-healing wounds or fractures;
  • 18. Coagulopathy (INR >1.5 or aPTT >1.5×ULN), bleeding diathesis, or requiring therapeutic anticoagulation:
  • Known bleeding disorders (hemophilia, coagulopathies) or thrombocytopenia
  • Hemoptysis (>2.5 mL/day) within 2 months
  • Clinically significant bleeding within 3 months (GI bleeding, hemorrhagic ulcers, etc.)
  • Chronic anticoagulation (warfarin/heparin) or antiplatelet therapy (aspirin ≥300 mg/day or clopidogrel ≥75 mg/day)
  • 19. Major surgical procedures within 4 weeks prior to study or anticipated during treatment;
  • 20. History within 6 months of:
  • GI perforation/fistula
  • Arterial/venous thromboembolism (excluding stable cerebral infarcts)
  • 21. Clinically significant pleural/peritoneal effusions requiring intervention (asymptomatic minimal effusions not requiring treatment may be permitted);
  • 22. Severe malnutrition;
  • 23. Active substance abuse or psychiatric disorders impairing compliance;
  • 24. Other active malignancies except:
  • Curatively treated malignancies with >2 year disease-free interval
  • Adequately treated non-melanoma skin cancer or lentigo maligna
  • Carcinoma in situ with complete resection
  • 25. Pregnancy or lactation;
  • 26. Any condition deemed by investigators to compromise patient safety or study integrity;
  • 27. Participation in other clinical trials within 30 days prior to enrollment or planned during study period.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan

Other trials in China

About this study

To evaluate the efficacy and safety of anlotinib combined with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression

Read the detailed description

Evaluation of the efficacy and safety of anlotinib in combination with TQB2450 and the SOX regimen as first-line treatment for advanced gastric cancer with low PD-L1 expression. Additionally, real-world data were collected from hospital-based patients receiving immune checkpoint inhibitor (ICI)-combined chemotherapy as first-line therapy for PD-L1-low advanced gastric cancer to establish an external control cohort. The efficacy outcomes between the two treatment strategies were then compared.

Being tested
anlotinib +TQB2450 + Oxaliplatin+S-1
Medical subject headings
Adenocarcinoma

What participants receive

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

  • anlotinib +TQB2450 + Oxaliplatin+S-1Drug

    Anlotinib: 10mg, po, d1-14,q3w,until disease progression or unacceptable toxicity.

    TQB2450: 1200mg, iv, d1, q3w,until disease progression or unacceptable toxicity. Oxaliplatin: 130mg/㎡, iv, d1,6 cycles.

    S-1:40mg, po, bid, d1~14,6 cycles.

Study groups in NCT06939452
Study groupRoleWhat they receive
anlotinib +TQB2450 + Oxaliplatin+S-1ExperimentalNot described
Receives: Drug: anlotinib +TQB2450 + Oxaliplatin+S-1

What is being measured

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

  1. Objective Response Rate(ORR)

    The RECIST1.1 standards were used to evaluate the efficacy of drugs.

    Measured: about 2 years

Secondary outcomes (4)

  1. Disease Control Rate(DCR)

    Measured: about 2 years

  2. Progression Free Survival(PFS)

    Measured: about 2 years

  3. Duration of Response(DOR)

    Measured: about 2 years

  4. 1-year OS rate

    Measured: about 1 year

Timeline

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

  1. First posted22 Apr 2025
  2. Study start7 Jun 2023
  3. Primary completion1 Jun 2026 (estimated)
  4. Study completion1 Jun 2026 (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
37 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06939452
Sponsor's protocol ID
IMMUNOVA
Status last verified
Apr 2026
First submitted
15 Apr 2025
Last updated
7 Apr 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing anlotinib +TQB2450 + Oxaliplatin+S-1 in people with Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma, run by Yongxu Jia 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 43 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: under way, not looking for participants, as of the sponsor's last update on 7 Apr 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?

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(ORR) (time frame: about 2 years). 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 NCT06939452.

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 7 Apr 2026.

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