Iparomlimab and Tuvonralimab (QL1706) Plus Lenvatinib and Chemotherapy for Extrapulmonary Neuroendocrine Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorWest China Hospital
About this trial
The aim of this prospective, randomized, controlled clinical trial is to evaluate the efficacy and safety of iparomlimab and tuvonralimab injection (QL1706) plus lenvatinib and etoposide-based platinum chemotherapy, consisting of etoposide plus cisplatin or carboplatin, compared with etoposide-based platinum chemotherapy alone as first-line treatment for patients with extrapulmonary neuroendocrine carcinoma. Potential predictive biomarkers will also be explored through analyses of tumor tissue, peripheral blood, and relevant clinical and pathological data.
Eligibility criteria
Qualifiers
Histologically and/or cytologically confirmed locally advanced unresectable or metastatic extrapulmonary neuroendocrine carcinoma. Eligible primary sites include the gastrointestinal tract, pancreas, biliary tract, and other extrapulmonary organs. Neuroendocrine carcinoma of the digestive system must be diagnosed according to the 2019 World Health Organization Classification of Tumours of the Digestive System.
Age ≥18 years, with no restriction on sex.
Life expectancy of at least 12 weeks.
Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
Disqualifiers
Histologically confirmed neuroendocrine tumor, mixed adenoneuroendocrine carcinoma, or other non-neuroendocrine carcinoma pathological types.
History of another malignancy with a disease-free interval of less than 5 years, except for adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, or a gastrointestinal tumor confirmed to have been cured by endoscopic mucosal resection.
Uncontrolled hypertension despite medical treatment, defined as systolic blood pressure >150 mmHg or diastolic blood pressure >90 mmHg.
Urine protein ≥2+ on routine urinalysis or 24-hour urinary protein ≥1 g.
Trial design
Treatments tested in this trial
- Iparomlimab and tuvonralimab injection (QL1706) + Lenvatinib + EP/EC
- EP/EC
Treatment groups
92 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov