NCT07148427Not yet recruitingPhase 2
Immunotherapy Combined With Anti-angiogenic Therapy and Chemotherapy for Gastric/Gastroesophageal Junction Adenocarcinoma
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
Source: ClinicalTrials.gov · Last updated 29 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 24 Aug 2025
- Start date
- 20 Sept 2025
- Primary completion date
- 30 Dec 2027
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical University
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07148427
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 20 Sept 2025 to the primary completion date, 30 Dec 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- 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.
Other illness
- 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).
Other
- Known HER2-positive expression (immunohistochemistry \[IHC\] 3+ or 2+ with a fluorescence in situ hybridization HER2:CEP17 ratio ≥2).
- Known central nervous system metastases and/or carcinomatous meningitis.
Who the study is looking for
- 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:
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.