A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With Iparomlimab and Tuvonralimab Injection, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk

Plain English Summary

A Prospective, Single-Arm, Exploratory Study of the Safety and Efficacy of Neoadjuvant Treatment With QL1706, an Anti-PD-1/Anti-CTLA-4 Bispecific Antibody, in Resectable Stage IB and IIA Hepatocellular Carcinoma With High Recurrence Risk is a Phase 2 clinical trial sponsored by Tianjin Medical University Cancer Institute and Hospital studying HCC - Hepatocellular Carcinoma, Iparomlimab and Tuvonralimab Injection, Neoadjuvant Immunotherapy. This study tests a new combination of immunotherapy drugs given before surgery for liver cancer. It is for patients with early-stage liver cancer (Stage IB and IIA) that has a high risk of returning after surgery. Participants will receive two cycles of the study drug before their scheduled surgery. Alternative treatments may include surgery alone, or other therapies depending on the cancer's stage and spread. The trial aims to enroll 30 participants.

Official Summary

This study aims to investigate the efficacy and safety of neoadjuvant therapy with Iparomlimab and Tuvonralimab Injection (anti-PD-1 and anti-CTLA-4 antibody combination) in patients with resectable hepatocellular carcinoma at high risk of recurrence (Stage IB, Stage IIA).

Who Can Participate

Here is what you need to know about eligibility for this trial. Patients aged 18 to 75 with a specific type of liver cancer (hepatocellular carcinoma) that can be surgically removed. Patients must have good liver function and a good general health status (ECOG 0-1). Patients with certain high-risk features of their tumor, such as size or number of tumors, may be eligible. Patients who have had prior cancer treatments like radiation or chemotherapy, or have active autoimmune diseases, may not be eligible. This trial is studying HCC - Hepatocellular Carcinoma, Iparomlimab and Tuvonralimab Injection, Neoadjuvant Immunotherapy, so participants generally need a confirmed diagnosis.

What They're Measuring

The study will measure how many patients are still alive and free from cancer after 1 year, indicating how well the treatment prevents the cancer from coming back. The specific primary outcome measures are: 1-year disease-free survival rate (2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 2, which tests whether the treatment actually works against the target condition. Phase 2 trials involve 100-300 patients and continue to monitor safety while evaluating effectiveness. This phase often tests different dosages to find the optimal amount. About 33% of Phase 2 drugs advance to Phase 3. If successful, the treatment will move to large-scale Phase 3 trials needed for FDA approval.

Why This Trial Matters

This trial addresses a need for more effective treatments before surgery for liver cancer, aiming to reduce the risk of the cancer returning. Phase 2 success would typically lead to larger Phase 3 trials needed for regulatory approval. This research targets HCC - Hepatocellular Carcinoma, Iparomlimab and Tuvonralimab Injection, Neoadjuvant Immunotherapy, where improved treatment options are needed.

Investor Insight

This trial explores a novel bispecific antibody for a significant unmet need in early-stage liver cancer, potentially offering a new treatment option and representing an investment in advanced immunot Phase 2 trials have approximately a 15-20% chance of eventually gaining FDA approval.

Is This Trial Right for Me?

Ask your doctor if this treatment is right for you, considering your specific cancer stage and health. Participation involves receiving the study drug intravenously before surgery and regular follow-up appointments. You will need to use effective birth control during the study and for a period afterward. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: NA
• Model: SINGLE_GROUP
• Masking: NONE
• Enrollment: 30 participants

Interventions

• DRUG: Iparomlimab and Tuvonralimab — Patients in the neoadjuvant Iparomlimab and Tuvonralimab group received 2 cycles of 7.5 mg/kg iv d1 q3w, followed by elective surgery 2-3 weeks thereafter.

Primary Outcomes

• 1-year disease-free survival rate (2 years)

Secondary Outcomes

• Incidence of microvascular invasion (MVI) (2 years)
• Pathological complete response (pCR) rate (2 years)
• Objective response rate (ORR) (2 years)
• 2-year disease-free survival (DFS) rate (3 years)
• Overall survival (OS) rate (5 years)

Full Eligibility Criteria

Inclusion Criteria:

* Patients voluntarily participate in this study and sign the informed consent form.
* Aged 18 to 75 years, male or female.
* ECOG Performance Status (PS) score of 0 to 1.
* Child-Pugh liver function classification: Grade A.
* Histopathologically confirmed primary hepatocellular carcinoma (HCC), and the lesions meet the surgical resection indications specified in the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022 Edition).
* Preoperatively, evaluated by the investigator, with high recurrence risk factors, meeting at least one of the following: Stage IB: Single tumor with maximum diameter \> 5 cm; 2-3 tumors with maximum tumor diameter ≤ 3 cm；Stage IIA: 2-3 tumors with maximum tumor diameter \> 3 cm.
* According to the RECIST 1.1 criteria, the patient has at least one measurable lesion (measurable lesion with a long diameter ≥ 10 mm on CT/MRI scan or lymph node lesion with a short diameter ≥ 15 mm on CT/MRI scan, and the measurable lesion has not received local treatment such as radiotherapy or cryotherapy).
* Expected survival time ≥ 6 months
* possess normal and sound organ function
* Females of childbearing age must agree to use contraceptive measures (such as intrauterine device, contraceptives or condoms) during the medication period and within 6 months after the end of medication; serum or urine pregnancy test is negative within 7 days before study enrollment, and must be a non-lactating patient; males must agree to use contraceptive measures during the study period and within 6 months after the end of the study.
* The subject has good compliance and is willing to cooperate with follow-up.

Exclusion Criteria:

* Previous radiotherapy, chemotherapy, concurrent chemoradiotherapy or other targeted therapy.
* Known hilar cholangiocarcinoma, sarcomatoid HCC, mixed cell carcinoma and fibrolamellar carcinoma; other active malignant tumors except HCC within 5 years or concurrently.
* Hypertension that cannot be well controlled with antihypertensive drugs (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg); previous hypertensive crisis or hypertensive encephalopathy.
* The subject has a history of other malignant tumors (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) or concurrent malignant tumors.
* Previous treatment with Iparomlimab and Tuvonralimab or other PD-1/PD-L1/CTLA-4 inhibitors; known previous allergy of the subject to macromolecular protein preparations or any component of Iparomlimab and Tuvonralimab.
* The subject has any active autoimmune disease or a history of autoimmune disease (such as, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism); subjects with vitiligo or asthma that was completely relieved in childhood and does not require any intervention in adulthood can be included; subjects with asthma requiring medical intervention with bronchodilators cannot be included.
* The subject is using immunosuppressants, or systemic or absorbable local hormone therapy for immunosuppressive purposes (dose \> 10 mg/day prednisone or other hormones with equivalent efficacy), and continues to use them within 2 weeks before enrollment.
* Clinically symptomatic ascites or pleural effusion requiring therapeutic paracentesis or drainage.
* Uncontrolled clinical symptoms or diseases of the heart, such as: Heart failure of NYHA Class II or above；Unstable angina pectoris；Myocardial infarction within 1 year；Patients with clinically significant supraventricular or ventricular arrhythmia requiring treatment or intervention.
* The patient currently (within 3 months) has esophageal varices, active gastroduodenal ulcer, ulcerative colitis, portal hypertension and other digestive tract diseases, or active bleeding from unresected tumors, or other conditions judged by the investigator that may cause gastrointestinal bleeding or perforation.
* Previous or current severe bleeding (bleeding \> 30 ml within 3 months), hemoptysis (\> 5 ml of fresh blood within 4 weeks) or thromboembolic events (including stroke events and/or transient ischemic attack) within 12 months.
* The subject has an active infection or unexplained fever \> 38.5 ℃ during screening or before the first dose (fever caused by tumor can be included as judged by the investigator).
* Patients with objective evidence of previous or current pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, drug-related pneumonia, severe impairment of lung function, etc.
* The subject has congenital or acquired immunodeficiency, such as HIV infection, or active hepatitis (transaminase does not meet the inclusion criteria; for hepatitis B: HBV DNA ≥ 10⁴/ml; for hepatitis C: HCV RNA ≥ 10³/ml); chronic hepatitis B virus carriers with HBV DNA \< 2000 IU/ml (\< 10⁴ copies/ml) can be enrolled only if they receive antiviral treatment du

Frequently Asked Questions

Related Conditions

• Hepatocellular Carcinoma
• Liver Cancer
• Gastrointestinal Cancers
• Immunotherapy
• Oncology
• Neoadjuvant Therapy
• Cancer Recurrence
• Targeted Therapy
• Bispecific Antibodies
• Hepatitis B

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