Phase II Study of Trastuzumab Rezetecan Combined With Adebrelimab and Lenvatinib in Advanced HER2-Positive/Low-Expression Biliary Tract Cancer

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking Union Medical College Hospital

About this trial

An investigation into the survival outcomes, progression-free survival, and safety of triple therapy with Trastuzumab Rezetecan, Adebrelimab, and Lenvatinib in patients with advanced HER2-positive/low-expressing biliary tract cancer after the failure of at least two prior systemic therapies.

Eligibility criteria

Qualifiers

The subjects voluntarily participated in the study and agreed to sign the written informed consent form, and they had good compliance.

Age: 18 years or above, Gender: Open to al

Locally advanced or metastatic cholangiocarcinoma confirmed by pathological histology or cytology, including cholangiocarcinoma (intrahepatic cholangiocarcinoma, extrahepatic cholangiocarcinoma) and gallbladder cancer

Having progressed or experienced intolerance after at least one systemic treatment regimen in the past

Disqualifiers

Histopathological examination confirmed that the bile duct tumors were of non-adenocarcinoma pathological types such as ampullary carcinoma, small cell carcinoma, neuroendocrine tumor, sarcoma, mucinous cystic tumor, etc

Having another active malignant tumor within 5 years or simultaneously, excluding cervical carcinoma in situ that has been fully treated, as well as skin basal cell or squamous cell carcinoma

The adverse reactions from previous anti-tumor treatments have not yet recovered to a NCI-CTCAE v5.0 rating of ≤ 1 (excluding cases of hair loss, meeting the numerical requirements of the inclusion criteria, or other situations judged by the investigator not to affect the treatment with the study drug)

Any disease evidence determined by the researchers (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension, moderate or severe ascites with clinical symptoms; uncontrollable or moderate to large amounts of pleural effusion, pericardial effusion, accompanied by acute or chronic uncontrolled pancreatitis, active bleeding disorders, active infections, active ILD/interstitial lung disease, severe chronic gastrointestinal diseases related to diarrhea, mental disorders/socioeconomic conditions) or the history of allogeneic organ or syngeneic bone marrow transplantation that the researchers consider makes the subject unsuitable for participation in the study or affects the compliance with the study protocol

Trial design

Treatments tested in this trial

  • Trastuzumab Rezetecan
  • Adebrelimab
  • Lenvatinib

Treatment groups

70 Participants
are divided into 2 treatment groups