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Not yet recruitingNCT07148427Updated Aug 29, 2025

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

A Phase 2 interventional study of Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy in Gastric/Gastroesophageal Junction Adenocarcinoma, sponsored by The First Affiliated Hospital with Nanjing Medical University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-29.

Sponsored by The First Affiliated Hospital with Nanjing Medical University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Gastric/Gastroesophageal Junction Adenocarcinoma

Keywords

  • regorafenib
  • chemotherapy
  • Iparomlimab and Tuvonralimab
03

In context

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.

    8. History of immunodeficiency, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation.

    9. Patients who have previously received anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibodies at any time.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy

    Drug: Iparomlimab and Tuvonralimab combination with regorafenib and chemotherapy

Interventions

  • DrugIparomlimab and Tuvonralimab combination with regorafenib and chemotherapy

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

06

What researchers measure

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)

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

    Time frame: Up to approximately 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07148427
Lead sponsor
The First Affiliated Hospital with Nanjing Medical University
Responsible party
Sponsor
First posted
Aug 29, 2025
Start date
Sep 20, 2025 (estimated)
Primary completion
Dec 30, 2027 (estimated)
Completion
Sep 2028 (estimated)
Last update
Aug 29, 2025

Study contacts

Hao Wu, Professor
Contact
+8613913855335

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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