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حالة التجربة السريرية NCT07487662 (ACTION-001) لـ Hepato Cellular Carcinoma (HCC) هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
جامعة سون يات سينTACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk (ACTION-001) المرحلة الثانية ١٠٥ علاج مناعي علاج موجه دولية
Recently, data from a phase III clinical study, inv...
عرض المزيدTACE or Ablation Combined With Sintilimab and Ipilimumab N01 as Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma With Intermediate-High Recurrence Risk: A Multicenter, Multigroup, Randomized, Phase Ⅱ Exploratory Clinical Trial
- ACTION-001
- IIT-2026-010 (معرف آخر) (the First Affliated Hospital of Sun Yat-sen University)
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةTACE/ablation+ anti-CTLA-4+anti-PD-1 therapy Patients in this trial group will receive two cycles of neoadjuvant therapy with sintilimab combined with ipilimumab N01, administered every 3 weeks (q3w). One week after the first cycle of treatment, the multidisciplinary team (MDT) will determine to perform either TACE or ablation according to the lesion status. Surgical treatment will be performed 2 weeks after the completion of the second cycle of neoadjuvant dru...عرض المزيد | sintilimab 200mg ivdrip q3w ipilimumab N01 3mk/kg ivdrip q3w TACE TACE will be performed in accordance with the standard procedures of the respective medical centers.Based on the judgment of the MDT team, patients with at least one lesion amenable to complete ablation will receive ablation therapy.Patients without any lesion amenable to complete ablation will receive TACE therapy. الاستئصال Ablation will be performed in accordance with the standard procedures of the respective medical centers.Based on the judgment of the MDT team, patients with at least one lesion amenable to complete ablation will receive ablation therapy.Patients without any lesion amenable to complete ablation will receive TACE therapy. |
تجريبيةTACE/ablation+ anti-CTLA-4+anti-PD-1+lenvatinib therapy Patients in this trial group will receive two cycles of neoadjuvant therapy with sintilimab combined with ipilimumab N01 and lenvatinib, administered every 3 weeks (q3w). One week after the first cycle of treatment, the multidisciplinary team (MDT) will determine to perform either TACE or ablation according to the lesion status. Surgical treatment will be performed 2 weeks after the completion of the second cycle of ...عرض المزيد | sintilimab 200mg ivdrip q3w ipilimumab N01 3mk/kg ivdrip q3w Lenvatinib 8mg P.O QD TACE TACE will be performed in accordance with the standard procedures of the respective medical centers.Based on the judgment of the MDT team, patients with at least one lesion amenable to complete ablation will receive ablation therapy.Patients without any lesion amenable to complete ablation will receive TACE therapy. الاستئصال Ablation will be performed in accordance with the standard procedures of the respective medical centers.Based on the judgment of the MDT team, patients with at least one lesion amenable to complete ablation will receive ablation therapy.Patients without any lesion amenable to complete ablation will receive TACE therapy. |
تجريبيةanti-CTLA-4+anti-PD-1 therapy Patients in this trial group will receive two cycles of neoadjuvant therapy with sintilimab combined with ipilimumab N01, administered every 3 weeks (q3w). Surgical treatment will be performed 2 weeks after the completion of the second cycle of neoadjuvant drug therapy. Adjuvant therapy with sintilimab will be initiated 4 weeks postoperatively, given every 3 weeks for a maximum of 15 cycles. | sintilimab 200mg ivdrip q3w ipilimumab N01 3mk/kg ivdrip q3w |
تجريبيةanti-CTLA-4+anti-PD-1+lenvatinib therapy Patients in this trial group will receive two cycles of neoadjuvant therapy with sintilimab combined with ipilimumab N01 and lenvatinib, administered every 3 weeks (q3w). Surgical treatment will be performed 2 weeks after the completion of the second cycle of neoadjuvant drug therapy. Adjuvant therapy with sintilimab and lenvatinib will be initiated 4 weeks postoperatively, given every 3 weeks for a maximum of 15 cyc...عرض المزيد | sintilimab 200mg ivdrip q3w ipilimumab N01 3mk/kg ivdrip q3w Lenvatinib 8mg P.O QD |
بدون تدخلSurgery alone Patients in this trial arm will undergo resection within 7 days after randomization, followed by regular postoperative follow-up. | غ/م |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
1-year recurrence-free survival rate | The proportion of subjects who did not experience tumor recurrence or death within 1 year after surgery. | One year |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
major pathological response rate, MPR rate | The proportion of patients with histologically confirmed tumor necrosis of more than 90% in the surgically resected specimens. | 5 weeks |
Objective response rate, ORR | The proportion of patients who achieve complete response (CR) and partial response (PR) in tumor assessment according to the RECIST 1.1 criteria after neoadjuvant therapy and before surgical resection. | 5 weeks |
Adverse Events, AE | The proportion of patients who experienced grade ≥3 hematological or non-hematological adverse events from the start of treatment to the end of follow-up. | One year |
1) Age: 18-75 years old; 2) Patients with hepatocellular carcinoma (HCC) classified as CNLC stage Ib-IIIa (excluding patients with Vp3 and Vp4), and deemed resectable by multidisciplinary team (MDT) discussion;
3) No prior tumor-related treatment received;
4) At least one measurable target lesion according to the RECIST 1.1 criteria;
5) ECOG PS score of 0-1;
6) Liver function classification: Child-Pugh Class A;
7) Estimated survival time ≥ 12 weeks;
8) Hematological, liver, and renal functions meet the following criteria:
Hemoglobin concentration ≥ 90 g/L;
Neutrophil count ≥ 1.5 × 10⁹/L;
Platelet count ≥ 75 × 10⁹/L;
Total bilirubin ≤ 1.5 × ULN (Upper Limit of Normal);
AST and ALT < 5 × ULN; ALP < 4 × ULN;
Creatinine ≤ 1.5 × ULN;
INR ≤ 1.5 × ULN; APTT ≤ 1.5 × ULN;
Serum albumin concentration ≥ 30 g/L;
9) Women of childbearing age must be excluded from pregnancy;
10) For patients with other concurrent malignant tumors, MDT discussion must confirm that the history and treatment history of other tumors will not interfere with the efficacy and safety evaluation of this study protocol;
11) Ability to understand and sign the informed consent form.
1) Prior history of HCC treatment; 2) Tumor rupture and bleeding, or suspected peritoneal metastasis;
3) History of other complex surgeries within 6 weeks;
4) Prior history of organ transplantation;
Currently receiving treatment in other clinical trials;
5) Prior history of autoimmune diseases, inflammatory disorders (such as inflammatory bowel disease, etc.), diverticulitis, systemic lupus erythematosus, sarcoidosis syndrome, Wegener's syndrome (granulomatosis with polyangiitis, rheumatoid arthritis, etc.), except for the following cases: vitiligo or alopecia areata, hypothyroidism with stable condition after drug replacement therapy, chronic skin diseases that do not require systemic treatment, and celiac disease controllable by diet alone;
6) Prior history of allergy to anti-PD1 drugs or anti-CTLA4 drugs, or allergy to chemical molecules similar to the above drugs, or prior severe allergic reaction to other monoclonal antibodies;
7) Uncontrollable intermittent recurrent diseases, including but not limited to: persistent infections (including tuberculosis), hypertension uncontrollable by drugs (> 140/90 mmHg), interstitial lung disease, severe chronic gastrointestinal diseases complicated with diarrhea, mental illness or social disorders that cannot comply with clinical research requirements, factors with high risk of side effects, and inability to sign the informed consent form;
8) Patients with prior hepatic encephalopathy, refractory ascites, or esophagogastric varices with high bleeding risk; patients with upper gastrointestinal bleeding within 1 year before the first administration;
9) Untreated active hepatitis B subjects (HBsAg positive and HBV-DNA exceeding 5000 copies/mL (1000 IU/mL) or higher than the lower limit of detection, whichever is higher); for subjects with hepatitis B, anti-hepatitis B virus treatment is required during the study treatment; active hepatitis C subjects (HCV antibody positive and HCV-RNA level higher than the lower limit of detection);
10) Patients with primary brain tumors (except meningiomas or other benign brain tumors), or any brain metastases, leptomeningeal carcinomatosis, epilepsy uncontrollable by conventional drugs, or new-onset stroke within 1 year;
11) Primary immunodeficiency disease;
12) Prior positive HIV test or acquired immunodeficiency syndrome (AIDS);
13) Use of immunosuppressive drugs within 14 days before the start of study treatment. The following situations are exempt:
Intranasal, inhaled, topically used steroids or local steroid injections;
Systemic application of corticosteroids not exceeding the physiological dose (e.g., 10 mg/day prednisone or its equivalent);
Steroid application for the treatment of allergic reactions;
14) Vaccination with live-attenuated vaccines within 30 days before the start of study treatment. Note: Live-attenuated vaccines should also be avoided during the study treatment and within 30 days after the end of treatment;
15) Receipt of systemic immunostimulant treatment within the prior 4 weeks;
16) Prior history of severe systemic diseases, including: myocardial infarction or unstable angina pectoris, hypertensive crisis or hypertensive encephalopathy, congestive heart failure of NYHA Class II or above, unstable symptomatic arrhythmia requiring drug intervention, severe vascular disease or symptomatic peripheral vascular disease, occurring within 12 months before the start of study treatment;
17) History of coagulative, hemorrhagic or thrombotic diseases within 12 months before the start of study treatment;
18) Severe, irreversible trauma, ulcers or fractures;
19) Pregnant or lactating women, or subjects planning to have children during the trial period;
20) Dependent on parenteral nutrition to maintain life;
21) Other acute or chronic diseases, mental and psychological diseases, etc., which are not suitable for participating in this study, as judged by the researcher.
جامعة سون يات سين1239 تجارب سريرية نشطة للاستكشافInnovent Biologics (Suzhou) Co. Ltd.