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

NCT06939452 | Recruiting Phase 2

• 1 other identifier: IMMUNOVA
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Advanced Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate(ORR)

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

  about 2 years

Secondary Outcomes (4)

• Disease Control Rate(DCR)

  about 2 years

• Progression Free Survival(PFS)

  about 2 years

• Duration of Response(DOR)

  about 2 years

• 1-year OS rate

  about 1 year

Study Arms (1)

anlotinib +TQB2450 + Oxaliplatin+S-1

EXPERIMENTAL

Drug: anlotinib +TQB2450 + Oxaliplatin+S-1

Interventions

anlotinib +TQB2450 + Oxaliplatin+S-1 DRUG

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.

anlotinib +TQB2450 + Oxaliplatin+S-1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Willing and able to provide written informed consent and comply with study procedures.
• \. 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).
• \. Disease recurrence \>6 months after completion of (neo)adjuvant chemotherapy or radiotherapy.
• \. 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.
• \. Age 18-75 years.
• \. ECOG performance status 0-1.
• \. Life expectancy ≥3 months.
• \. 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
• \. 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.
• \. PD-L1 combined positive score ( CPS) \<5

You may not qualify if:

• \. Prior treatment with anlotinib hydrochloride or any immune checkpoint inhibitors (anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies);
• \. History of immunodeficiency disorders, including HIV infection, other acquired or congenital immunodeficiency diseases, or prior organ transplantation;
• \. Active hepatitis B or C infection, or active pulmonary tuberculosis;
• \. CT-confirmed ulcerative lesions or fecal occult blood positivity;
• \. History of clinically significant bleeding (excluding epistaxis) within 1 month prior to enrollment;
• \. Previous allogeneic bone marrow or solid organ transplantation;
• \. Interstitial lung disease including idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia, or CT-confirmed active pneumonia;
• \. Administration of live attenuated vaccines within 4 weeks before study initiation or anticipated during the study through 5 months post-treatment;
• \. Systemic corticosteroids (\>10 mg/day prednisone equivalent) or immunosuppressive therapy within 2 weeks prior to study initiation (inhaled or topical corticosteroids are permitted);
• \. 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;
• \. Conditions impairing oral drug absorption (e.g., dysphagia, chronic diarrhea, or intestinal obstruction);
• \. Grade ≥2 peripheral neuropathy per NCI CTCAE v5.0;
• \. Active infections requiring systemic antibiotics within 14 days prior to study entry;
• \. Hepatic tumor burden exceeding 50% of total liver volume;
• \. Bone metastases with impending spinal cord compression risk;

Sponsors & Collaborators

• Yongxu Jia: lead

Study Sites (1)

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

MeSH Terms

Conditions

Adenocarcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Yongxu Jia

  The First Affiliated Hospital of Zhengzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongxu Jia

CONTACT

0086-15237128281; fccjiayx@zzu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: June 7, 2023
• Primary Completion: June 7, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-03

Locations

CN (1)