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A real-world study on the treatment of advanced first-line gastric / esophageal cancer with low expression of PD-L1 with Iparomlimab and Tuvonralimab Injection

A real-world study on the treatment of advanced first-line gastric / esophageal cancer with low expression of PD-L1 with Iparomlimab and Tuvonralimab Injection

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500101828
Enrollment
Unknown
Registered
2025-04-30
Start date
2025-04-30
Completion date
Unknown
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric / esophageal cancer

Interventions

Sponsors

Henan Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Study participants voluntarily participate in this study, sign an informed consent form, and have good compliance; 2. Age> = 18 years old; 3. Unresectable advanced or metastatic gastric or esophageal cancer. 4. No prior systemic therapy for advanced or metastatic gastric or esophageal cancer; For study participants who have received prior neoadjuvant/adjuvant chemotherapy or chemoradiotherapy for curative intent, the interval between disease progression and last treatment is at least 6 months; 5. Have at least 1 measurable lesion (according to RECIST 1.1 criteria); 6. ECOG score 0-2 points; 7. Expected survival>=12 weeks; 8.PD-L1 CPS<1; 9. Study participants of childbearing potential: Must agree to abstinence or use a reliable, effective method of contraception from the time of signing the informed consent form until at least 90 days after the last dose of study drug. and female study participants must have a negative serum or urine HCG test;

Exclusion criteria

Exclusion criteria: 1. Those who are allergic to apalolitovorelimab and its excipients; 2. Patients who are currently participating in other interventional clinical studies; 3. Pregnant and lactating females; 4. Has a severe concomitant disease or other comorbid disease that would interfere with the planned treatment, or any other condition that, in the opinion of the investigator, the patient is not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
Safety;

Secondary

MeasureTime frame
Objective response rate;Progression free survival;Disease control rate;Duration of remission;

Countries

China

Contacts

Public ContactLiu Ying

Henan Cancer Hospital

yaya7207@126.com+86 137 8360 4602

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026