A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectabl… (NCT06925516) | Clinical Trial Compass
RecruitingPhase 2
A Trial of Apatinib and Adebrelimab in Combination With Chemotherapy in Patients With Unresectable ICC
China38 participantsStarted 2025-01-22
Plain-language summary
The study aims to evaluate the efficacy and safety of Apatinib and Adebrelimab in Combination With chemotherapy in patients with advanced intrahepatic cholangiocarcinoma (ICC)
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* 1\. Provided informed consent and sign the informed consent form;
* 2\. Male or female, Aged 18-75 years (counted on the date of signing informed consent);
* 3\. Histologically or cytologically confirmed ICC;
* 4\. The patient is not a candidate for surgery, or the disease has progressed after prior surgery and/or local treatment.
* 5\. No previous systematic treatment for advanced ICC. Exceptions include patients who relapsed more than 6 months after adjuvant chemotherapy following radical resection. Local regional therapy (including but not limited to surgery, radiotherapy, hepatic artery embolization, TACE, hepatic arterial infusion, radiofrequency ablation, cryoablation or percutaneous ethanol injection) must have been completed at least 4 weeks prior to baseline radiological scanning, and any toxicity (except alopecia) induced by local regional therapy must have resolved to ≤ Grade 1 in accordance with National Cancer Institute - Common Terminology Criteria for Adverse Event version 5.0 (NCI-CTCAE v5.0);
* 6\. Have at least one measurable lesion (in accordance with RECIST v1.1, major diameter ≥ 10 mm of the measurable lesion in spiral CT scan or short diameter of swollen lymph node ≥ 15 mm; the lesion with previous local therapy can be used as target lesion after the progression is confirmed in accordance with RECIST v1.1)
* 7\. Child-Pugh class: Grade A;
* 8\. ECOG-PS score: 0-1;
* 9\. With a life expectancy of ≥ 12 weeks;
* 10\. Adequate major or…
What they're measuring
1
objective response rate (ORR)
Timeframe: 12 months
Trial details
NCT IDNCT06925516
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University