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NCT Number: NCT07148427

Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Gastric/Gastroesophageal Junction Adenocarcinoma

A single-arm, Phase II clinical study protocol of Apatolimab Tovolimab in combination with regorafenib and chemotherapy as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Willing to participate in this study and has signed the informed consent form.
  • Age greater than 18 years, regardless of gender.
  • Histologically confirmed unresectable locally advanced or metastatic G/GEJ adenocarcinoma.
  • No prior systemic treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma. Previous neoadjuvant and/or adjuvant therapy is acceptable, but all systemic treatments must have been completed at least 6 months prior to the diagnosis of unresectable or metastatic disease.
  • PD-L1 combined positive score (CPS) less than 1 as determined by tissue testing.
  • At least one measurable lesion according to RECIST 1.1 criteria.
  • ECOG performance status 0-1.
  • Life expectancy >3 months.
  • Adequate organ and marrow function:

Exclusion criteria

  • Known HER2-positive expression (immunohistochemistry [IHC] 3+ or 2+ with a fluorescence in situ hybridization HER2:CEP17 ratio ≥2).
  • Presence of other malignancies within 5 years prior to treatment, with the exception of adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally treated prostate cancer, and ductal carcinoma in situ (hormone therapy for non-metastatic prostate cancer or breast cancer is permitted).
  • Known central nervous system metastases and/or carcinomatous meningitis.
  • Patients with severe cardiac, pulmonary, hepatic, or renal dysfunction.
  • Hypertension that cannot be controlled with antihypertensive medications (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg).
  • History of bleeding within 4 weeks prior to screening, with any bleeding event graded as ≥3 according to CTCAE 5.0.
  • Thrombotic events (arterial or venous) within 6 months prior to screening, such as cerebrovascular accident, deep vein thrombosis (excluding previously thrombosed veins deemed healed by the investigator), and pulmonary embolism.
  • History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.
  • Patients who have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies at any time.

Treatment and study plan

Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy

Drug

Iparomlimab and Tuvonralimab:5mg/kg,Intravenous infusion,Q3W regorafenib:80mg,oral administration once daily from Day 1 to Day 14 chemotherapy:XELOX or SOX

Primary outcomes

  1. Objective response rate

    Time frame: Up to approximately 2 years

Secondary outcomes

  1. Progression-free survival (PFS)

    Time frame: Up to approximately 2 years

  2. Disease control rate (DCR)

    Time frame: Up to approximately 2 years

  3. Duration of response (DoR)

    Time frame: Up to approximately 2 years

  4. Overall survival (OS)

    Time frame: Up to approximately 5 years

  5. The incidence and severity of adverse events (AE) during the study period (Safety)

    Time frame: Up to approximately 2 years

    The incidence and severity of adverse events (AE) during the study period

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Wu, Professor

CONTACT

+8613913855335

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Registry information

Official study title

A Single-arm, Phase II Clinical Study Protocol of Lparomlimab and Tuvonralimab in Combination With Regorafenib and Chemotherapy as First-line Treatment for Locally Advanced or Metastatic Gastric/Gastroesophageal Junction Adenocarcinoma

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Aug 29, 2025
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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