Esophageal Squamous Cell Carcinoma (ESCC)
Conditions
Keywords
QL1706, lenvatinib, immune checkpoint blockades, esophageal squamous cell carcinoma, ESCC
Brief summary
The purpose of this study is to assess the efficacy and safety of QL1706 plus lenvatinib in second-line therapy for patients with metastatic esophageal squamous cell carcinoma after progression on immune checkpoint inhibitor therapy
Interventions
5mg/kg , iv, q3w
DRUGLenvatinib
8 mg or 12 mg QD via oral capsule
Sponsors
The First Affiliated Hospital of Zhengzhou University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects participate voluntarily and sign informed consent. 2. 18-75 years, male or female. 3. Histologically or cytologically verified diagnosis of unresectable locally advanced or metastatic esophageal squamous cell carcinoma 4. Patients who have disease progression verified by imaging on standard first-line immunotherapy with anti-PD-1/PD-L1 antibodies 5. At least 1 measurable target lesion according to Response Evaluation in Solid Tumors (RECIST 1.1). 6. ECOG PS 0-1
Exclusion criteria
1. Presence of any active autoimmune disease or history of autoimmune disease (such as: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, nephritis, hyperthyroidism) 2. Those who are taking immunosuppressants or systemic hormonal therapy for immunosuppressive purposes (dose\> 10 mg/day prednisone or other equivalent cortiremonial hormones) and are taking within 2 weeks before recruitment 3. Severe allergic reaction to other monoclonal antibodies 4. Those who terminated treatment due to related toxicity during anti-PD-1/PD-L1 antibody treatment 5. Prior treatment with bispecific anti-PD-1/CTLA-4 checkpoint blockades or VEGFR inhibitors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase Ib：Dose Limiting Toxicities (DLTs) and recommended phase 2 dose (PR2D) | up to ~21 days | Hematologic DLTs are defined as: 1. Grade 4 neutropenia lasting for ≥7 days 2. febrile neutropenia not associated with the underlying disease, 3. Grade 3 thrombocytopenia with bleeding, Grade ≥3 thrombocytopenia requiring platelet transfusion, Grade 4 thrombocytopenia, . |
| Phase II: Overall Survival (OS) in all participants | up to ~48 months | OS is defined as the time from the first administration to death due to any cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | up to ~42 months | PFS is defined as the time from the first administration to the first documented progressive disease (PD) per RECIST 1.1 by investigators or death due to any cause, whichever occurs first. |
| ORR | up to ~42 months | ORR is defined as the percentage of participants with Complete Response or Partial Response per RECIST 1.1 assessed by the investigators. |
| DOR | up to ~42 months | For participants who demonstrate a confirmed CR or PR, per RECIST 1.1 by the investigators, DOR is defined as the time from first documented evidence of CR or PR until PD or death. |
| Number of Participants With AEs | Up to ~53 months | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. |
Contacts
Primary ContactProfessor Wang
Outcome results
None listed