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

NCT06818773 | Not Yet Recruiting Phase 4

• 1 other identifier: EC-FB-SC-09-V1.3
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Metastatic Biliary Tract Cancer; HER2 Positive

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  12 months

Secondary Outcomes (5)

• Progression-Free Survival (PFS)

  12 months

• Disease Control Rate (DCR)

  12 months

• Overall Survival (OS)

  24 months

• Quality of Life Questionnaire-Core 30（QLQ-C30）

  24months

• Adverse Event（AE）

  24 months

Study Arms (1)

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

EXPERIMENTAL

Drug: Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor

Interventions

Inetetamab + Gemcitabine + Cisplatin ± PD-1/PD-L1 inhibitor DRUG

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.

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Gemcitabine

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Central Study Contacts

Shen Feng, MD.; PhD

CONTACT

8616628552926; shenfengdfgd@163.com

Feng Xie, MD

CONTACT

13386272885@189.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the Clinical Research Institute, Director of the Department

Study Record Dates

• First Submitted: December 29, 2024
• First Posted: February 10, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 10, 2025

Record last verified: 2025-02