Combination of QLS31905 and Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: QLS31905 for Injection, Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, QL2107 Injection.
- Who it may be relevant to
- Registry conditions: CLDN18.2-positive Advanced Biliary Tract Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase II Clinical Study to Evaluate the Efficacy and Safety of QLS31905 for Injection in Combination With Chemotherapy ± QL2107 in Patients With CLDN18.2-positive Advanced Biliary Tract Cancer
Overview
This is an open-label, multicenter Phase II clinical study aimed at evaluating the efficacy, safety, PK profile, and immunogenicity of QLS31905 for Injection combined with Chemotherapy ± QL2107 in Patients with CLDN18.2-positive Advanced Biliary Tract Cancer
Interventions
- Drug QLS31905 for Injection
QLS31905 for Injection - Drug Gemcitabine Hydrochloride for Injection
Gemcitabine Hydrochloride for Injection - Drug Cisplatin for Injection
Cisplatin for Injection - Drug QL2107 Injection
QL2107 Injection - Drug Oxaliplatin Injection
Oxaliplatin Injection - Drug Capecitabine Tablets
Capecitabine Tablets
Primary outcome measures
- ORR (Objective Response Rate) [Time frame: Approximately 24 months]
Eligibility criteria
Inclusion criteria
- Subjects with unresectable locally advanced or metastatic Biliary Tract Cancer confirmed by histopathological or cytological examination;
- Subjects with at least one measurable lesion designated as a target lesion, as assessed by the investigator according to RECIST v1.1. Lesions that have received radiotherapy or other local treatments may be considered measurable if they demonstrate imaging PD;
- No prior systemic anti-tumor treatment for locally advanced or metastatic Biliary Tract Cancer.
Exclusion criteria
- Subjects with a known history of severe or repeated allergy, intolerance, or contraindication to QLS31905, QL2107, or other large molecule protein preparations, as well as Gemcitabine Hydrochloride for Injection, Cisplatin for Injection, Oxaliplatin Injection or Capecitabine Tablets and any components in their preparations;
- Subjects had other second primary malignancies within 5 years prior to the first dose;
- Subjects with clinically significant hemorrhage within 3 months before the first dose;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07151872 · QLS31905-205