Inetetamab Plus Chemotherapy ± PD-1/PD-L1 in HER2+ Advanced Biliary Cancer

Efficacy and Safety Study of Inetetamab Combined with Chemotherapy ± PD-1/PD-L1 Inhibitor As First-Line Treatment for HER2-Positive Advanced Biliary Tract Cancer

To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.

Study Overview

• Status: Not yet recruiting
• Conditions: Metastatic Biliary Tract Cancer; HER2 Positive
• Intervention / Treatment: Drug: Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shen Feng, MD.; PhD; Phone Number: 8616628552926; Email: shenfengdfgd@163.com
• Study Contact Backup: Name: Feng Xie, MD; Email: 13386272885@189.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males or females aged ≥18 years;
• Histologically confirmed HER2-positive metastatic biliary tract cancer;
• ECOG performance status of 0 to 1;
• No prior treatment with anti-HER2 therapies;
• Patients have not received any systemic anticancer treatment in the recurrent/metastatic setting;
• Patients who have experienced disease recurrence more than 6 months after curative surgery; if adjuvant therapy (chemotherapy and/or radiotherapy) was received post-surgery, patients must have had recurrence more than 6 months after completion of adjuvant therapy;
• Presence of at least one measurable lesion;
• Adequate function of major organs as defined by the following criteria;
• Estimated survival of ≥3 months;
• Voluntary participation in this study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.

Exclusion Criteria:

• Known allergy or contraindication to any component of the study drugs;
• Previous treatment with anti-HER2 therapies;
• Prior use of immunotherapy;
• Use of immunosuppressive agents within 14 days before the first dose, except:

Intranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg/day prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)

• Known active central nervous system metastases or carcinomatous meningitis;
• Other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer;
• Major surgery or significant trauma within 4 weeks before randomization, or planned major surgery;
• Severe cardiac disease;
• Resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen;
• Neuropathy ≥ Grade I per NCI criteria;
• Active interstitial lung disease (ILD) or pulmonary disease requiring bronchodilators;
• History of immunodeficiency;
• Participation in another drug trial within 4 weeks before screening;
• Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study;
• Any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: inetetamab+ Gemcitabine + Cisplatin ± PD-1/PD-L1 Inhibitor

Drug: Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor; A 21-day cycle is used, with the initial dose of inetuximab at 8 mg/kg (IV), followed by 6 mg/kg (IV) on Day 1 of each subsequent cycle. Gemcitabine (1000 mg/m²) + cisplatin (25 mg/m²) are administered in combination on Day 1 and Day 8 of each cycle. The appropriate PD-1/PD-L1 inhibitor will be selected by the investigator based on the patient's specific condition, and its administration will strictly follow the dosing instructions provided in the relevant drug's package insert.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Objective Response Rate (ORR)	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall Survival (OS)	24 months
Progression-Free Survival (PFS)	12 months
Disease Control Rate (DCR)	12 months
Quality of Life Questionnaire-Core 30（QLQ-C30）	24months
Adverse Event（AE）	24 months

Collaborators and Investigators

• Sponsor: Eastern Hepatobiliary Surgery Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 29, 2024
• First Submitted That Met QC Criteria: February 7, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 7, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Biliary Tract Diseases; Biliary Tract Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Immune Checkpoint Inhibitors; Gemcitabine
• Other Study ID Numbers: EC-FB-SC-09-V1.3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No