RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2

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Brief Title

RC48-ADC Combinatioed Envolizumab in Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2

Official Title

RC48-ADC in Combination With Envolizumab for the First-line Treatment of Locally Advanced or Metastatic Biliary Tract Cancer With Positive HER-2: A Prospective, Single-arm Phase II Trial.

Brief Summary

      This study was a prospective, single-arm phase II clinical trial to observe and evaluate the
      efficacy and safety of RC48-ADC combined envafolimab in the first-line treatment of locally
      advanced or metastatic biliary tract cancer with positive HER-2.
    


Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

ORR

Secondary Outcome

 DCR

Condition

Biliary Tract Cancer

Intervention

RC48-ADC

Study Arms / Comparison Groups

 RC48-ADC plus envafolimab
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

29

Start Date

August 2022

Completion Date

August 2025

Primary Completion Date

August 2024

Eligibility Criteria

        Inclusion Criteria:

          -  18 years;

               -  ECOG 0-1;

               -  patients diagnosed by pathological or cytological diagnosis of locally advanced
                  or metastatic biliary tract cancer (include intrahepatic cholangiocarcinoma,
                  extrahepatic cholangiocarcinoma, gallbladder and ampullary carcinoma);

               -  life expectancy of at least 3 months;

               -  HER2 IHC 2+ or 3+;

               -  At least one measurable objective tumor lesion according to RECIST 1.1;

               -  Not received systemic chemotherapy in the past. Patients who have completed
                  adjuvant therapy or neoadjuvant therapy before the start of the chemotherapy
                  regimen in this trial 6 months ago can be included in this trial.

               -  satisfactory main organ function (laboratory test must meet the following
                  criteria): hemoglobin (HGB) ≥90g/L, neutrophil count (ANC) ≥1.5×109/L, platelet
                  count (PLT) ≥80×109/L, Serum creatinine (CR) ≤1.5 upper normal limitation (UNL),
                  total bilirubin (TBil) ≤1.5 upper normal limitation (UNL), alanine
                  aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 UNL (For
                  patients with liver metastasis, the AST/ALT must be ≤5.0 UNL), left ventricular
                  ejection fraction (LVEF) ≥ 50%;

               -  Subjects of childbearing potential must use an appropriate method of
                  contraception during the study period and within 120 days after the end of the
                  study, have a negative serum pregnancy test within 7 days prior to study
                  enrollment, and must be non-lactating subjects;

        Exclusion Criteria:

          -  Previously received drug therapy against PD-1/PD-L1 inhibitor and other Antibody
             conjugate drug (Such as T-DM1 and DS8201);

          -  Allergic to the active ingredients or excipients of the study drug;

          -  biliary obstruction were excluded. Unless blockage is treated locally, such as
             endoscopic stenting, percutaneous hepatic drainage, etc., total bilirubin is reduced
             below the upper limit of 1.5 UNL;

          -  A history of malignancies other than biliary tract malignancies (other than cured
             carcinoma in situ of the cervix or basal cell carcinoma of the skin and other
             malignancies cured for 5 years);

          -  Received major surgical treatment, incisional biopsy, or significant traumatic injury
             within 28 days prior to the start of study treatment; or had a long-term unhealed
             wound or fracture;

          -  Unsuitable for the study or other chemotherapy determined by investigator.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Liangjun Zhu, +8613905199123, [email protected]



Administrative Informations


NCT ID

NCT05417230

Organization ID

2022-030


Responsible Party

Principal Investigator

Study Sponsor

Jiangsu Cancer Institute & Hospital


Study Sponsor

Liangjun Zhu, Study Chair, Jiangsu Cancer Institute & Hospital


Verification Date

June 2022