AFP Gastric or Gastroesophageal Junction AdenocarcinomaPhase 2NCT07289997
Iparomlimab and Tuvonralimab Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC)
A Phase 2 study testing Iparomlimab and Tuvonralimab Injection (QL1706) in people with AFP Gastric or Gastroesophageal Junction Adenocarcinoma and PD-1/CTLA-4, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This study is a single-arm study aimed at evaluating the efficacy and safety of Iparomlimab and Tuvonralimab Injection combined with apatinib and irinotecan hydrochloride in the treatment of advanced alpha-fetoprotein gastric cancer (AFPGC) that progresses from first-line PD-1 combined with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AFP Gastric or Gastroesophageal Junction Adenocarcinoma, PD-1/CTLA-4, AFPGC
- What is being tested?
- Iparomlimab and Tuvonralimab Injection (QL1706)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2025to Sep 2028
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily join this study and sign the informed consent form;
- Age≥18 years, both male and female are acceptable.
- Unresectable，Locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has been diagnosed by histopathological or cytological examination, with serum alpha-fetoprotein > 20.0 ng/mL at the time of diagnosis. There is at least one measurable lesion (according to the RECIST v1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10 mm or the short diameter of the enlarged lymph node is ≥15 mm; lesions that have received local treatment in the past can be used as target lesions after comfirmed progression according to the RECIST v1.1).
- Failure of previous first-line PD-1 combined chemotherapy treatment (disease progression during or after treatment); Those who relapse within 6 months (less than 183 days) after the end of adjuvant/neoadjuvant chemotherapy (oxaliplatin combined with fluorouracil) can be included in the study, and PD-1 inhibitors need to be combined in the first-line treatment.
- ECOG 0-1;
- Expected survival time ≥12 weeks;
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- The functions of vital organs within 7 days before enrollment meet the following requirements (no blood components or cell growth factors are allowed to be used within 14 days before enrollment) :
- <1> Absolute neutrophil count ≥1.5×109/L; <2> platelet count ≥80×109/L; <3>Hemoglobin ≥9g/dL; <4>Total bilirubin < 1.5 times ULN; <5>ALT and AST < 2.5 times ULN (< 5 times ULN in patients with liver metastasis); <6> serum creatinine ≤1 times ULN; <7>The endogenous creatinine clearance rate ≥ 50ml/min.
- Women of childbearing age should take effective contraceptive measures.
- Good compliance and cooperation with follow-up visits.
Who cannot join
- Inability to comply with the research plan or procedures;
- It is known to be in a HER2-positive state;
- Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other tissue types, or adenocarcinoma mixed with other tissue types of gastric cancer;
- The patient currently has any diseases or conditions that affect the absorption of the drug;
- Combined with severe cardiovascular diseases, such as uncontrollable heart failure, coronary heart disease, arrhythmia, uncontrollable hypertension, etc.
- Patients with active brain metastases. Patients with asymptomatic brain metastases who have not received prior treatment and whose total number of brain metastases is ≤3 and the longest diameter is < 1cm can be enrolled. Patients who have previously received treatment for brain metastases can be enrolled if they are clinically stable, have no evidence of new or expanded brain metastases, and have not used steroids for ≥14 days before the study intervention.
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- Known to be allergic to the drug used in this test;
- Previously received immune checkpoint inhibitors other than anti-PD-1 /PD-L1 antibodies or other drugs/antibodies acting on T-cell co-stimulation or checkpoint pathways;
- Significant clinically significant bleeding symptoms or a clear bleeding tendency occurred within 3 months before enrollment; Gastrointestinal perforation and/or gastrointestinal fistula occurred within 6 months before enrollment; Arterial/venous thrombotic events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, etc.
- Clinically uncontrolled active infections, such as acute pneumonia, active hepatitis B or hepatitis C (previous history of hepatitis B virus infection regardless of drug control, hepatitis B virus DNA≥1×104 copies /mL or 2000 IU/ml);
- Known history of primary immunodeficiency or active pulmonary tuberculosis;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- There is a known history of human immunodeficiency virus (HIV) infection (i.e., HIV antibody positive);
- Significant malnutrition (weight loss of 5% within one month of signing the informed consent form or 15% within three months, or a reduction of half or more in food intake within one week), except for more than four weeks after the correction of malnutrition before the administration of the first dose of the study drug;
- History of other primary malignant tumors, excluding:
- <1>Malignant tumors that achieved complete remission for at least 2 years before enrollment and did not require additional treatment during the study period; <2>Non-melanoma skin cancer or malignant freckle-like nevus that has been fully treated and has no evidence of disease recurrence; <3>Carcinoma in situ that has received adequate treatment and has no evidence of disease recurrence.
- Female patients who are pregnant or breastfeeding;
- According to the researcher's judgment, those with concomitant diseases that seriously endanger the patient's safety or affect the patient's completion of the study;
- The researchers considered patients unsuitable for inclusion in this study.
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, 1 recruiting
- Recruiting
Hebei Medical University Fourth Hospital
Shijiazhuang, Hebei, 050000
Fengbin Zhang, +86 13931151403, zhangfengbin1981@163.com
About this study
Official title: Iparomlimab and Tuvonralimab Injection Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC) That Progresses From First-line PD-1 Combined Chemotherapy, A Prospective, Single-arm, Phase II Clinical Study
This study is a single-arm study aimed at evaluating the efficacy and safety of Iparomlimab and Tuvonralimab Injection combined with apatinib and irinotecan hydrochloride in the treatment of advanced alpha-fetoprotein gastric cancer (AFPGC) that progresses from first-line PD-1 combined with chemotherapy. The study enrolled patients with advanced gastric cancer and gastroesophageal junction cancer whose serum alpha-fetoprotein was greater than 20.0 ng/mL at the initial diagnosis and progressed after first-line PD-1 combined chemotherapy in a single center of the Fourth Hospital of Hebei Medical University. All patients underwent gastroscopy and were pathologically confirmed as Her-2 negative gastric adenocarcinoma, and had received PD-1 inhibitor treatment as the first-line treatment. Staged examinations include enhanced CT of the abdominal and pelvic cavities, plain CT scan of the chest, and color Doppler ultrasound of superficial lymph nodes. The enrolled patients received apalolitovolrelimab 5.0mg/kg, Q3W, d1; Apatinib mesylate, 0.25g, once daily; Irinotecan hydrochloride, 200mg/m², Q3W, d1. Combination therapy until the patient's disease progresses, or intolerable toxic and side effects occur, or until death or withdrawal of informed consent, or up to two years.
The primary endpoint of the study was to assess the objective response rate (ORR) of combination therapy. Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and the incidence of adverse events, etc
- Conditions
- AFP Gastric or Gastroesophageal Junction Adenocarcinoma, PD-1/CTLA-4, AFPGC, Immunotherapy
- Being tested
- Iparomlimab and Tuvonralimab Injection (QL1706)
- Keywords
- immunotherapy, AFPGC, PD-1/CTLA-4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iparomlimab and Tuvonralimab Injection (QL1706)Drug
- Iparomlimab and Tuvonralimab Injection， 5.0mg/kg, Q3W, D1;
- Apatinib, 0.25g, once daily, orally; Irinotecan, 200mg/m², Q3W, D1; Combination therapy until the patient's disease progresses, or intolerable toxic and side effects occur, or until death or withdrawal of informed consent, or up to two years.
| Study group | Role | What they receive |
|---|---|---|
| Iparomlimab and Tuvonralimab Injection combined with apatinib and irinotecan | Experimental | 1. Iparomlimab and Tuvonralimab Injection， 5.0mg/kg, Q3W, D1;
2. Apatinib, 0.25g, once daily, orally; Irinotecan, 200mg/m², Q3W, D1; Combination therapy until the patient's disease progresses, or intolerable toxic and side effects occur, or until death or withdrawal of informed consent, or up to two years. Receives: Drug: Iparomlimab and Tuvonralimab Injection (QL1706) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The objective response rate (ORR), which is the proportion of patients with complete response and partial response as assessed according to the RECIST1.1 criteria
Measured: 24months
Secondary outcomes (4)
Progression-free survival (PFS)
The period from the start of treatment to disease progression, death from any cause, or the end of follow-up, whichever occurs first
Measured: 36month
Overall survival (OS)
The time from the start of treatment to death due to any cause or the end of follow-up
Measured: 48months
Disease control rate (DCR)
Disease control rate (DCR) : It refers to the proportion of patients who achieved PR、CR and SD after treatment. DCR=CR+PR+SD
Measured: 24months
Adverse Events（AEs）
Incidence of adverse events
Measured: 36months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start28 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AFP Gastric or Gastroesophageal Junction AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07289997
- Sponsor's protocol ID
- 2025KY011
- Status last verified
- Oct 2025
- First submitted
- 4 Dec 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iparomlimab and Tuvonralimab Injection Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC) That Progresses From First-line PD-1 Combined Chemotherapy, A Prospective, Single-arm, Phase II Clinical Study
- ClinicalTrials.gov ID
- NCT07289997
- Acronym / sponsor ID
- 2025KY011
- Conditions
- AFP Gastric or Gastroesophageal Junction Adenocarcinoma, PD-1/CTLA-4, AFPGC, Immunotherapy
- Keywords
- immunotherapy, AFPGC, PD-1/CTLA-4
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 28 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Dec 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.
This study is a single-arm study aimed at evaluating the efficacy and safety of Iparomlimab and Tuvonralimab Injection combined with apatinib and irinotecan hydrochloride in the treatment of advanced alpha-fetoprotein gastric cancer (AFPGC) that progresses from first-line PD-1 combined with chemotherapy. The study enrolled patients with advanced gastric cancer and gastroesophageal junction cancer whose serum alpha-fetoprotein was greater than 20.0 ng/mL at the initial diagnosis and progressed after first-line PD-1 combined chemotherapy in a single center of the Fourth Hospital of Hebei Medical University. All patients underwent gastroscopy and were pathologically confirmed as Her-2 negative gastric adenocarcinoma, and had received PD-1 inhibitor treatment as the first-line treatment. Staged examinations include enhanced CT of the abdominal and pelvic cavities, plain CT scan of the chest, and color Doppler ultrasound of superficial lymph nodes. The enrolled patients received apalolitovolrelimab 5.0mg/kg, Q3W, d1; Apatinib mesylate, 0.25g, once daily; Irinotecan hydrochloride, 200mg/m², Q3W, d1. Combination therapy until the patient's disease progresses, or intolerable toxic and side effects occur, or until death or withdrawal of informed consent, or up to two years.
The primary endpoint of the study was to assess the objective response rate (ORR) of combination therapy. Secondary endpoints included progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and the incidence of adverse events, etc
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 Injection combined with apatinib and irinotecan | Experimental | Drug: Iparomlimab and Tuvonralimab Injection (QL1706)1. Iparomlimab and Tuvonralimab Injection， 5.0mg/kg, Q3W, D1; 2. Apatinib, 0.25g, once daily, orally; Irinotecan, 200mg/m², Q3W, D1; Combination therapy until the patient's disease progresses, or intolerable toxic and side effects occur, or until death or withdrawal of informed consent, or up to two years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Voluntarily join this study and sign the informed consent form;
- Age≥18 years, both male and female are acceptable.
- Unresectable，Locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction that has been diagnosed by histopathological or cytological examination, with serum alpha-fetoprotein > 20.0 ng/mL at the time of diagnosis. There is at least one measurable lesion (according to the RECIST v1.1, the long diameter of the measurable lesion on spiral CT scan is ≥10 mm or the short diameter of the enlarged lymph node is ≥15 mm; lesions that have received local treatment in the past can be used as target lesions after comfirmed progression according to the RECIST v1.1).
- Failure of previous first-line PD-1 combined chemotherapy treatment (disease progression during or after treatment); Those who relapse within 6 months (less than 183 days) after the end of adjuvant/neoadjuvant chemotherapy (oxaliplatin combined with fluorouracil) can be included in the study, and PD-1 inhibitors need to be combined in the first-line treatment.
- ECOG 0-1;
Key exclusion criteria (19 listed)
- Inability to comply with the research plan or procedures;
- It is known to be in a HER2-positive state;
- Gastric cancer known to be squamous cell carcinoma, undifferentiated carcinoma or other tissue types, or adenocarcinoma mixed with other tissue types of gastric cancer;
- The patient currently has any diseases or conditions that affect the absorption of the drug;
- Combined with severe cardiovascular diseases, such as uncontrollable heart failure, coronary heart disease, arrhythmia, uncontrollable hypertension, etc.
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 and Tuvonralimab Injection (QL1706)1. Iparomlimab and Tuvonralimab Injection， 5.0mg/kg, Q3W, D1; 2. Apatinib, 0.25g, once daily, orally; Irinotecan, 200mg/m², Q3W, D1; Combination therapy until the patient's disease progresses, or intolerable toxic and side effects occur, or until death or withdrawal of informed consent, or up to two years. | Drug | Iparomlimab and Tuvonralimab Injection combined with apatinib and irinotecan |
Primary outcome
Objective response rate (ORR)
Time frame: 24months
The objective response rate (ORR), which is the proportion of patients with complete response and partial response as assessed according to the RECIST1.1 criteria
4 secondary outcomes
Progression-free survival (PFS)
Time frame: 36month
Overall survival (OS)
Time frame: 48months
Disease control rate (DCR)
Time frame: 24months
Adverse Events（AEs）
Time frame: 36months
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 17 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for AFP Gastric or Gastroesophageal Junction Adenocarcinoma
Not yet recruitingPhase 2
Efficacy of Sintilimab Combined With Bevacizumab and XELOX/SOX in Initially Unresectable AFP-positive Gastric/Gastroesophageal Junction Adenocarcinoma
Gastric Cancer (GC), AFP Gastric or Gastroesophageal Junction Adenocarcinoma
Not yet recruitingPhase 2
Sintilimab Plus Apatinib and SOX as First-line Treatment in Patients With AFP Gastric or Gastroesophageal Junction Adenocarcinoma
AFP Gastric or Gastroesophageal Junction Adenocarcinoma
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 Phase 2 study testing Iparomlimab and Tuvonralimab Injection (QL1706) in people with AFP Gastric or Gastroesophageal Junction Adenocarcinoma and PD-1/CTLA-4, run by Hebei Medical University Fourth Hospital 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 10 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 17 Dec 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Fengbin Zhang (+8613931151403, zhangfengbin1981@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 24months). 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 17 Dec 2025.