A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined Wā¦ (NCT07229846) | Clinical Trial Compass
Not Yet RecruitingPhase 2
A Single-arm, Single-center, Phase II Clinical Study of Aipalolitovorelizumab (QL1706) Combined With Bevacizumab and Standard Chemotherapy as First-line Treatment for MSS/pMMR Metastatic Colorectal Cancer With BRAF V600E Mutation
China30 participantsStarted 2026-02
Plain-language summary
This is an open-label, single-arm, single-center phase II clinical study, aiming to investigate the safety and efficacy of Aipalolitovorelizumab (QL1706) combined with bevacizumab plus standard chemotherapy regimen as first-line treatment for patients with MSS/pMMR metastatic colorectal cancer harboring BRAF V600E mutation.
Patients will receive intravenous administration of Aipalolitovorelizumab (QL1706) injection + bevacizumab + oxaliplatin/irinotecan/fluorouracil/calcium folinate, along with oral capecitabine. After completing the corresponding treatment cycles, patients will enter the maintenance treatment phase as determined by the researcher. In the maintenance treatment phase, a 3-week treatment regimen of Aipalolitovorelizumab (QL1706) injection combined with bevacizumab and capecitabine will be adopted, with the administration method and dosage remaining unchanged.
The primary endpoint of this study is objective response rate (ORR); the secondary endpoints include progression-free survival (PFS), overall survival (OS), disease control rate (DCR), duration of response (DOR), and safety.
Who can participate
Age range18 Years ā 75 Years
SexALL
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Inclusion criteria
ā. Aged 18-75 years (inclusive of 18 and 75 years) at the time of signing the ICF, male or female;
ā. Patients with histopathologically confirmed unresectable metastatic colorectal adenocarcinoma of MSS/pMMR type with known BRAF V600E mutation;
ā. Expected survival period ā„ 12 weeks;
ā. No prior systemic antineoplastic drug treatment for metastatic colorectal adenocarcinoma (if the patient has previously received XELOX chemotherapy while waiting for genetic testing results, and meets other inclusion criteria as assessed by the researcher, they can be enrolled in the treatment);
ā. For subjects who have received neoadjuvant/adjuvant therapy previously, the time from the last treatment to recurrence or progression must exceed 6 months;
ā. Adverse events (AEs) related to previous treatment have recovered to grade ā¤ 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) (except for alopecia);
ā. According to the RECIST version 1.1 criteria, the researcher assesses that there is at least one measurable lesion, which should not have received local treatment such as radiotherapy (lesions located in the previously irradiated area can also be regarded as eligible measurable lesions if progression is confirmed);
. Routine blood tests: No blood transfusion or use of blood products within 14 days. White blood cell count \> 3000/Āµl, absolute neutrophil count (ANC) ā„ 1500 cells/Āµl, platelet count ā„ 75,000/Āµl, hemoglobin ā„ 9.0 g/dL, left ventricular ejection fraction (LVEF) ā„ 50%, Fridericia-corrected QT interval (QTcF) \< 470 milliseconds, activated partial thromboplastin time (APTT) ā¤ 1.5 times the upper limit of normal (ULN);
Exclusion criteria
ā. Have other active malignant tumors within 5 years before the first administration of the study drug. Patients with cured localized tumors such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the prostate, carcinoma in situ of the cervix, and carcinoma in situ of the breast can be enrolled;
ā. Have central nervous system (CNS) or leptomeningeal metastasis;
ā. Have received radiotherapy within 6 months before the start of study treatment; except for palliative radiotherapy for bone lesions performed more than 14 days before the start of study treatment; radiotherapy covering more than 30% of the bone marrow area within 28 days before the first administration is not allowed;
ā. Have previously received treatment with targeted drugs against EGFR or VEGF/vascular endothelial growth factor receptor (VEGFR) targets (including bevacizumab, cetuximab, panitumumab, aflibercept, regorafenib, or biosimilars of the above drugs, etc.);
ā. Have previously received any T-cell co-stimulation or immune checkpoint inhibitor therapy, including but not limited to CTLA-4 inhibitors, PD-1 inhibitors, PD-L1/2 inhibitors, or other T-cell-targeted drugs;
ā. Have a known history of severe allergy to any study drug analogs or study drug excipients;
ā. Pleural effusion, pericardial effusion that cannot be controlled by appropriate intervention, or ascites that requires frequent drainage;
ā. Have had cerebrovascular accident, myocardial infarction, unstable angina, or poorly controlled arrhythmia (including QTc interval ā„ 450 ms in males and ā„ 470 ms in females) within half a year (QTc interval is calculated by Fridericia formula);