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New treatment option for AFP Gastric or Gastroesophageal Junction Adenocarcinoma
Official title Iparomlimab and Tuvonralimab Combined With Apatinib and Irinotecan Hydrochloride for the Treatment of Advanced Alpha-fetoprotein-producing Gastric Cancer (AFPGC)
ClinicalTrials.gov ID: NCT07289997
What this study is testing
What is Iparomlimab and Tuvonralimab Injection (QL1706)?
Iparomlimab and Tuvonralimab Injection (QL1706) is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for afp gastric or gastroesophageal junction adenocarcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Failure of previous first-line PD-1 combined chemotherapy treatment (disease progression during or after treatment); Those who relapse within 6...
- ECOG 0-1;
You likely can't join if
- 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...
- 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...
- Patients with active brain metastases. Patients with asymptomatic brain metastases who have not received prior treatment and whose total number of...
See the full eligibility criteria
- 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...
- 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...
- ECOG 0-1;
- Expected survival time ≥12 weeks;
- 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) : \ Absolute neutrophil...
- Women of childbearing age should take effective contraceptive measures.
- Good compliance and cooperation with follow-up visits.
- 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...
- 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...
- 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...
- 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...
- History of other primary malignant tumors, excluding: \ Malignant tumors that achieved complete remission for at least 2 years before enrollment and did not require additional treatment during the study period; \...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shijiazhuang, Hebei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shijiazhuang, Hebei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.