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

ConditionsMetastatic Biliary Tract CancerHER2 Positive
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorEastern Hepatobiliary Surgery Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

Known allergy or contraindication to any component of the study drugs;

Previous treatment with anti-HER2 therapies;

Prior use of immunotherapy;

Known active central nervous system metastases or carcinomatous meningitis;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

35 Participants
are divided into 1 treatment group
Group A: inetetamab+ Gemcitabine + Cisplatin ± PD-1/PD-L1 InhibitorExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Time frame
12 months

Secondary outcomes

1

Progression-Free Survival (PFS)

Time frame
12 months
2

Disease Control Rate (DCR)

Time frame
12 months
3

Overall Survival (OS)

Time frame
24 months
4

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

Time frame
24months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Eastern Hepatobiliary Surgery Hospital

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: