NCT07139587Not yet recruiting
The Efficacy and Safety of Iparomlimab/Tuvonralimab (Anti PD-1/CTLA-4) Combined With Albumin-bound Paclitaxel in Second-line Treatment of Patients With Advanced Gastric/Gastroesophageal Junction Adenocarcinoma
Source: ClinicalTrials.gov · Last updated 10 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The goal of this clinical trial is to evaluate the efficacy and safety of Iparomlimab and Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-paclitaxel in the second-line treatment of patients with advanced gastric/gastroesophageal junction adenocarcinoma. The main questions it aims to answer are: 1. Can the combination of Iparomlimab/Tuvonralimab and albumin-paclitaxel for advanced gastric cancer/gastroesophageal junction cancer who has progressed or is intolerant to first-line SOC prolong the PFS and OS, improve ORR, DCR, and prolong DoR; 2. Whether Iparomlimab/Tuvonralimab ( anti PD-1/CTLA-4) combined with albumin-paclitaxel for second-line treatment remains effective for patients who have progressed from first-line PD-1±chemotherapy; 3. The safety and tolerability of Iparomlimab/Tuvonralimab in combination with albumin-paclitaxel for second-line treatment.Participants will:1. Use Iparomlimab/Tuvonralimab 5.0mg/kg, D1, Q3W; At least 30 minutes later, administer the chemotherapy albumin-paclitaxel: 260mg/m², D1, Q3W, and complete the infusion within 30 minutes. The combined regimen was administered every 3 weeks, with efficacy evaluated every 2 cycles (RECIST 1.1) until disease progression, intolerable toxicity or patient withdrawal.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 17 Aug 2025
- Start date
- Sept 2025
- Primary completion date
- Aug 2027
- Lead sponsor
- Qingxia Li
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07139587
What you commit to
- Study type: Interventional
- Planned participants: 30
- From Sept 2025 to the primary completion date, Aug 2027
- 1 site in 1 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
- Previously received PD-1/CTLA-4 bispecific antibody or taxanes at first-line treatment.
Other illness
- Her2-positive gastric cancer/gastroesophageal junction adenocarcinoma;
- Active autoimmune disease;
Who the study is looking for
- Aged 18-75;
- ECOG PS 0-2;
- Histologically confirmed advanced of the gastric cancer/gastroesophageal junction adenocarcinoma;
- Failure of first-line treatment: Progression or intolerance after receiving platinum-based (oxaliplatin/cisplatin) + fluorouracil (5-FU/ capecitabine /S-1) regimens;
- The first-line use of PD-1 inhibitors is permitted;
- At least one measurable lesion (RECIST v1.1);
- Good organ function (ANC≥1.5×109/L, PLT≥100×109/L, with normal liver and kidney functions）.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hebei General Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.