Gastric CancerNCT07139587
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
A study testing Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Qingxia Li at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Gastroesophageal Junction Adenocarcinoma
- What is being tested?
- Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Sep 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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）.
Who cannot join
- Her2-positive gastric cancer/gastroesophageal junction adenocarcinoma;
- Active autoimmune disease;
- Previously received PD-1/CTLA-4 bispecific antibody or taxanes at first-line treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Hebei General Hospital
Shijiazhuang, Hebei, 050000
Jia Chen, （+86）0311-85988973, utm5012@163.com
Qingxia Li, Professor
About this study
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.
- Being tested
- Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel
- Keywords
- Immunotherapy, gastric cancer, gastroesophageal junction adenocarcinoma, PD-1/CTLA-4
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxelDrug
Iparomlimab/Tuvonralimab : 5.0mg/kg, D1, Q3W Albumin-bound paclitaxel: 260mg/m², D1, Q3W
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab combined with albumin-paclitaxel | Experimental | Iparomlimab and Tuvonralimab: 5.0mg/kg, D1, Q3w; Albumin-paclitaxel: 260mg/m², D1, Q3w Receives: Drug: Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival（PFS）
Assessed by INV based on RECIST 1.1, defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first
Measured: 3 years
Secondary outcomes (5)
Overall survival（OS）
Defined as the time between the date of enrollment and the date of death (by any cause).
Measured: 4 years
Objective response rate（ORR）
Defined as the percentage of participants whose BOR is either a confirmed CR or PR（assessed by INV based on RECIST 1.1）
Measured: 3 years
Disease control rate（DCR）
Defined as the percentage of participants who have a BOR of CR, PR, SD, or NON-CR/NON-PD（assessed by INV based on RECIST 1.1）
Measured: 3 years
Duration of Responce （DoR）
Defined as the time from the first documented evidence of a response of CR or PR until the first documented disease progression or death due to any cause, whichever occurs first（assessed by INV based on RECIST 1.1）
Measured: 4 years
Adverse events
Incidence of AEs, SAEs, deaths and laboratory abnormalities in all treated participants
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingxia Li
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Qingxia Li, Hebei General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07139587
- Sponsor's protocol ID
- 2025-399
- Status last verified
- Sep 2025
- First submitted
- 17 Aug 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07139587
- Acronym / sponsor ID
- 2025-399
- Keywords
- Immunotherapy, gastric cancer, gastroesophageal junction adenocarcinoma, PD-1/CTLA-4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qingxia LiUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Iparomlimab and Tuvonralimab combined with albumin-paclitaxel | Experimental | Drug: Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxelIparomlimab and Tuvonralimab: 5.0mg/kg, D1, Q3w; Albumin-paclitaxel: 260mg/m², D1, Q3w |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (3 listed)
- Her2-positive gastric cancer/gastroesophageal junction adenocarcinoma;
- Active autoimmune disease;
- Previously received PD-1/CTLA-4 bispecific antibody or taxanes at first-line treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxelIparomlimab/Tuvonralimab : 5.0mg/kg, D1, Q3W Albumin-bound paclitaxel: 260mg/m², D1, Q3W | Drug | Iparomlimab and Tuvonralimab combined with albumin-paclitaxel |
Primary outcome
Progression-free survival（PFS）
Time frame: 3 years
Assessed by INV based on RECIST 1.1, defined as the time from enrollment to the first documented disease progression or death due to any cause, whichever occurs first
5 secondary outcomes
Overall survival（OS）
Time frame: 4 years
Objective response rate（ORR）
Time frame: 3 years
Disease control rate（DCR）
Time frame: 3 years
Duration of Responce （DoR）
Time frame: 4 years
Adverse events
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iparomlimab/Tuvonralimab (anti PD-1/CTLA-4) combined with albumin-bound paclitaxel in people with Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, run by Qingxia Li at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qingxia Li, Professor (+8613613110158, lqx73@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival（PFS） (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2025.