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New treatment option for ESCC
Official title AK112 Combined With Chemotherapy as the First-line Treatment in Advanced Esophageal Squamous Cell Carcinoma Patients
ClinicalTrials.gov ID: NCT06489197
What this study is testing
What is Ivonescimab combined with albumin paclitaxel and cisplatin?
Ivonescimab combined with albumin paclitaxel and cisplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for escc.
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 is a single arm，phase 2 study evaluating the safety and efficacy of Ivonescimab(AK112) combined with chemotherapy in the treatment of advanced esophageal squamous cell carcinoma (ESCC). In this study, patients with advanced esophageal squamous cell carcinoma who had not received any systematic treatment in the past will be enrolled.
- 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 to 75
You may be able to join if
- Signed the informed consent；
- Male or female patients ≥18 and ≤ 75 years old;
- ECOG physical status score is 0 or 1;
- Patients with non resectable or metastatic advanced ESCC confirmed by pathological ocytological examination;
- No previous systemic treatment;
You likely can't join if
- Local advanced esophageal squamous cell carcinoma that can be curative through surgery or potentially cured through radiation therapy;
- Suffering from other malignant tumors within the 5 years prior to enrollment. Patients with other malignant tumors that have been cured by local...
- Active bleeding signs of the lesion are displayed under endoscopy;
- Currently participating in intervention clinical research treatment, or having received other research drugs or used research instruments within 4...
- Receiving immunotherapy in the past, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT...
- Received systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within 2 weeks before the first...
See the full eligibility criteria
Who can join
- Signed the informed consent；
- Male or female patients ≥18 and ≤ 75 years old;
- ECOG physical status score is 0 or 1;
- Patients with non resectable or metastatic advanced ESCC confirmed by pathological ocytological examination;
- No previous systemic treatment;
- Expected survival time ≥ 3 months;
- Patients must have at least one measurable metastatic lesion according to RECIST version 1.1;
- Normal organ function:
- Hematology :Absolute neutrophil count (ANC) ≥ 1.5 × 109/L (1500/mm3); Platelet count ≥ 100 × 109/L (100000/mm3); Hemoglobin ≥ 90g/L;
- Kidney:The calculated value of creatinine clearance rate (CrCl) is ≥ 50 mL/min;Normal urine routine, urine protein\<2+or 24-hour (h) urine protein quantification\<1.0 g;
- Liver:Total serum bilirubin (TBiL) ≤ 1.5 × ULN;AST and ALT ≤ 2.5 × ULN; For people with liver metastasis, AST and ALT can be ≤ 5 × ULN;Serum albumin (ALB) ≥ 30g/L;
- Normal coagulation function, international standardized ratio (INR) ≤ 1.5 x ULN, prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤ 1.5 x ULN;
- Women of childbearing age must undergo a pregnancy test (serum or urine) with a negative result within 14 days before enrollment, and voluntarily use appropriate methods of contraception during the observation period...
- Comply with the scheduled visits, treatment plans, laboratory tests, and other requirements of the study;
What rules you out
- Local advanced esophageal squamous cell carcinoma that can be curative through surgery or potentially cured through radiation therapy;
- Suffering from other malignant tumors within the 5 years prior to enrollment. Patients with other malignant tumors that have been cured by local treatment, such as basal or cutaneous squamous cell carcinoma, superficial...
- Active bleeding signs of the lesion are displayed under endoscopy;
- Currently participating in intervention clinical research treatment, or having received other research drugs or used research instruments within 4 weeks before the first administration;
- Receiving immunotherapy in the past, including immune checkpoint inhibitors (such as anti-PD-1/L1 antibodies, anti-CTLA-4 antibodies, anti-TIGIT antibodies, anti-LAG3 antibodies, etc.), immune checkpoint agonists (such...
- Received systemic non-specific immunomodulatory therapy (such as interleukin, interferon, thymosin, etc.) within 2 weeks before the first administration;
- Active autoimmune diseases that require systemic treatment (such as the use of disease relieving drugs, glucocorticoids, or immunosuppressants) have occurred within 2 years prior to the first administration.
- The study is currently undergoing systemic glucocorticoid therapy (excluding local glucocorticoids through nasal spray, inhalation, or other routes) or any other form of immunosuppressive therapy within 7 days prior to...
- Clinically significant gastrointestinal obstruction, gastrointestinal perforation, intra-abdominal abscess, fistula formation, etc. occur within 6 months before the first administration;
- Active, uncontrolled, or recurrent inflammatory gastrointestinal diseases (such as Crohn's disease, ulcerative colitis, radiation enteritis, hemorrhagic enteritis, chronic diarrhea, etc.);
- Previous history of myocarditis, cardiomyopathy, and malignant arrhythmia. Unstable angina, myocardial infarction, congestive heart failure (classified as grade 2 or above according to the New York Heart Association...
- Any arterial thromboembolism events, NCI CTCAE 5.0 grade 3 or above venous thromboembolism events, transient ischemic attacks, cerebrovascular accidents, hypertensive crises, or hypertensive encephalopathy occurred...
- Severe infections occurring within 4 weeks prior to the first administration, including but not limited to comorbidities requiring hospitalization, sepsis, or severe pneumonia; Active infections that have received...
- people with active hepatitis B are required to receive anti hepatitis B virus treatment during the study treatment; Active hepatitis C people (HCV antibody positive and HCV RNA levels above the detection limit);
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- If the toxicity of previous anti-tumor treatments has not improved, it is defined as the toxicity has not returned to level 0 or 1 of NCI CTCAE 5.0, or the level specified in the inclusion/exclusion criteria, except for...
- Known to be allergic to any component of any investigational drug; Known medical history of severe hypersensitivity reactions to other monoclonal antibodies;
- If a live vaccine or attenuated live vaccine is administered within 30 days prior to the first administration, or if a live vaccine or attenuated live vaccine is planned to be administered during the study period, the...
- Known history of mental illness, drug abuse, alcohol or drug abuse;
- Pregnant or lactating women;
- Those who have undergone major surgical procedures or experienced severe trauma within 30 days prior to the first administration, or those who have planned major surgical procedures within 30 days after the first...
- During the screening period, imaging showed significant necrosis and cavities in the tumor, and the researchers determined that entering the study would pose a risk of bleeding; Tumors invade important blood vessels and...
- Have a history of severe bleeding tendency or coagulation dysfunction; There are significant clinically significant bleeding symptoms within one month prior to the first administration; Patients who have previously or...
- The researcher believes that there are other potential risks that are not suitable for participation in this study;
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, 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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, 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.