A Multiple Tumor Species, Open and Multi-center Clinical Study of Alpaloritovorelli Antibodies (Q… (NCT06760676) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Multiple Tumor Species, Open and Multi-center Clinical Study of Alpaloritovorelli Antibodies (QL-1706) Combined with Pulsed Low Dose Rate External Irradiation (PLDR) for Disease Progression After Previous Anti-tumor Therapy
90 participantsStarted 2025-12-01
Plain-language summary
For the recurrent and metastatic tumors after first-line treatment (such as lung cancer, esophageal cancer and cervical cancer), the risk of conventional fractionated secondary radiotherapy is high because the tumor is close to the hollow organs (such as heart, lung and small intestine). According to previous studies, combined chemotherapy regimens are often used, but the disease control rate (DCR) is limited, and drug resistance and poor tolerance of patients are prone to occur. The immune checkpoint inhibitors (ICB) has been considered as a new strategy for maintenance treatment of patients with recurrent and metastatic tumors, but only some patients can respond for a long time. Therefore, how to improve the clinical response rate of ICB has become an urgent problem to be solved. Pulsed low dose rate radiotherapy (PLDR), a new radiotherapy technology emerging in recent years, is expected to become a new way to solve the above difficulties. Alpaloritovorelli antibodies (QL-1706) is a new type of combination antibody independently developed by Qilu Pharmaceutical Co., Ltd. It is composed of IgG4 antibody targeting PD-1 (ipalorimab), and IgG1 antibody targeting CTLA-4 (tuvonralimab) in a fixed proportion. It has the synergistic mechanism of blocking PD-1 and CTLA-4 at the same time. The combination of these two antibodies forms a powerful synergistic effect and forms positive feedback in the tumor immune cycle.
Pulsed low dose rate radiotherapy (PLDR) is a safe and feasible option for recurrent tumors with high risk of re-radiotherapy. It also has therapeutic advantages for refractory and massive tumors. The advantages of combined vascular targeting and chemotherapy have been initially demonstrated. As a new anti-tumor therapy, immunotherapy has shown clinical benefits in many types of cancer, but the overall effective rate is still limited, which may be due to the immune "desertification" of the tumor microenvironment. PLDR irradiation is expected to reverse the tumor inhibitory microenvironment by inducing the release of tumor associated antigen and increasing the killing function of T cells, activate tumor immunity and improve the response rate of immunotherapy. Based on this, this study plans to take the lead in carrying out this prospective clinical study through the combination of PLDR external irradiation and ICB treatment (QL-1706).
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The subjects voluntarily joined this study, signed informed consent, had good compliance, and were willing to cooperate with follow-up;
. Male or female, age range of 18-75 years old (including 18 and 75 years old), gender not limited;
. Confirmed by pathology as esophageal cancer, non-small cell lung cancer, or cervical cancer;
. Expected survival period\>3 months;
. Patients who have progressed with first-line treatment in the past, (patients with local recurrence or distant metastasis of the tumor during (new) adjuvant therapy or ≤ 3 months after treatment are considered as first-line treatment)
. ECOG score 0-2 points;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combines a dual-checkpoint antibody called QL-1706 with a specific radiation technique called pulsed low dose rate external irradiation — since it's a Phase 1 study, what is currently known about the safety profile of this combination, and what kinds of side effects should I be prepared to discuss?
2Because this is a Phase 1 trial, the main focus is on safety and dosing rather than proving the treatment works — given my specific diagnosis of esophageal, cervical, or non-small cell lung cancer, would standard second-line or later treatment options give me more established benefit before considering an early-phase study like this?
3The trial is listed as 'not yet recruiting,' so what is your best estimate of when it might open, and how does that timeline fit with the urgency of my current situation?
4The trial is designed for patients whose cancer has progressed after previous anti-tumor therapy — based on my treatment history, do you think I would even be likely to meet the eligibility criteria once this study opens?
5The primary outcome being measured is objective response rate, meaning how many patients' tumors shrink — what does that tell us about what the researchers are still trying to learn, and how does that affect what I could realistically hope to gain from participating?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. According to RECIST 1.1 criteria, there must be at least one measurable extracranial lesion;
. The laboratory test results within one week before enrollment meet the following conditions: 1) Blood routine: HGB≥90g/L； WBC≥4.0×109/L； NEUT≥2.0×109/L； PLT ≥100×109/L； 2) Blood biochemistry: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN (ALT and AST ≤ 5 × ULN in patients with liver metastases); BUN and Cr ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min; 3) The results of cardiac ultrasound examination within the first two weeks of enrollment are consistent: left ventricular ejection fraction (LVEF)\>50%;
Exclusion criteria
. Patients with malignant tumors other than cervical cancer, esophageal cancer, and lung cancer;
. In the first 5 years of randomization, patients with other active malignant tumors, except for locally curable tumors that have been cured, such as skin squamous cell carcinoma, skin basal cell carcinoma, superficial bladder cancer, and breast cancer in situ;
. Patients who have participated in clinical trials of other drugs within the 4 weeks prior to enrollment, received radiation therapy targeting the target area within the 4 weeks prior to enrollment in this study, and received attenuated live vaccines within the 4 weeks prior to their first dose or planned to receive them during the study period; Within 4 weeks before the first administration, he received systematic treatment with traditional Chinese patent medicines and simple preparations with anti-tumor indications or Chinese herbal medicine with anti-tumor effect and drugs with immune regulation effect (such as thymosin, interferon, interleukin, etc.);
. Within 6 months, there have been incidents of arterial/venous thrombosis, such as cerebrovascular accidents (including temporary ischemic attacks, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism;
. Simultaneously receiving any other anti-tumor treatment;
. Individuals with a known history of allergies to the components of this medication regimen, a history of telangiectatic ataxia or other radiation hypersensitivity reactions;
. Subjects with active infectious diseases;
. Subjects with any severe and/or uncontrolled illnesses;