Esophageal CancerPhase 1NCT06760676
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
A Phase 1 study testing Pulsed low dose rate radiotherapy (PLDR) and Alpaloritovorelli antibodies in people with Esophageal Cancer and Non Small Cell Lung Cancer, run by Anhui Provincial Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Non Small Cell Lung Cancer, Cervical Cancer
- What is being tested?
- Pulsed low dose rate radiotherapy (PLDR) and Alpaloritovorelli antibodies
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 31 Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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%;
- Normal coagulation function, no active bleeding or thrombotic diseases;
- Patients without contraindications for radiotherapy;
- Patients of childbearing age who test negative for pregnancy and voluntarily adopt effective and reliable contraceptive measures during the trial period;
- Subjects who have received anti-tumor treatment in the past should be enrolled only after the toxic reactions of previous treatment have stabilized and returned to baseline levels (except for residual hair loss effects) or after the CTCAE v5.0 rating score is ≤ 1.
Who cannot join
- 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;
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- Subjects with active infectious diseases;
- Subjects with any severe and/or uncontrolled illnesses;
- Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results;
- According to the investigator's judgment, there are concomitant diseases (including but not limited to severe hypertension, severe pulmonary dysfunction/disease, and severe diabetes beyond the control of drugs) that seriously endanger the patient's safety or affect the patient's completion of the study;
- Having a clear history of neurological or mental disorders, including epilepsy or dementia, and being unable to cooperate with radiotherapy procedures;
- Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation;
- Known history of interstitial lung disease or non infectious pneumonia;
- Diagnosed with immunodeficiency or undergoing systemic corticosteroid therapy or any other form of immunosuppressive therapy, with active or potentially recurrent autoimmune diseases, except for vitiligo, hair loss, psoriasis, or eczema that do not require systemic treatment; Hypothyroidism caused by autoimmune thyroiditis only requires stable doses of hormone replacement therapy; Type I diabetes requiring only a stable dose of insulin replacement therapy.;
- Suffering from active or documented inflammatory bowel disease (such as Crohn's disease, ulcerative colitis), and active diverticulitis. Clinical manifestations of gastrointestinal obstruction, or the need for routine parenteral fluid replacement, parenteral nutrition, or indwelling gastric tube;
- There are symptomatic central nervous system (CNS) metastases, leptomeningeal metastases, or spinal cord compression caused by metastases prior to signing informed consent. Individuals without clinical symptoms, who have clinical and/or imaging evidence of stable condition, have stopped corticosteroid and anticonvulsant drug treatment for at least 2 weeks, and do not require further treatment (radiotherapy, surgical resection, and/or corticosteroid treatment) may participate in this study;
- There are currently cases of third interstitial fluid accumulation that require local treatment such as repeated puncture and drainage due to poor clinical control;
- Exclude subjects with any of the following cardiovascular diseases:
- Occurrence of myocardial infarction, unstable angina, pulmonary embolism, acute/persistent myocardial ischemia, cerebrovascular accident, transient ischemic attack, or other clinically significant/drug-induced arterial or venous thrombosis, embolism, or ischemic events within 6 months prior to the first administration;
- Past and/or current presence of NYHA class III-IV congestive heart failure;
- Previous and/or current severe arrhythmias requiring medication treatment;
- Before the first administration, the 12 lead ECG showed a mean QT interval (QTcF) of>470 ms.
- The researchers believe that the patient is not suitable to participate in any other circumstances of this study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the detailed description
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. PLDR technology was first proposed by Tom é et al in 2007, and was first applied to the re-radiotherapy of recurrent tumors by Richards and Charlie Ma et al. The primary principle is the low-dose high radiosensitivity (HRS) of radiobiology, that is, a certain low-dose level of radiotherapy can increase the radiosensitivity of tumor cells and reduce the toxicity of normal tissues at the same time.
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. The combination antibody can maintain normal PD-1 antibody exposure in vivo and reduce the half-life of CTLA-4 antibody with lower toxicity and better tolerance. At present, sufficient preclinical studies of alpaloritovorelli antibodies have been completed, and a number of clinical studies are under way. The mechanism of action, safe dose range, mode of administration, toxicity characteristics and pharmacological characteristics are clear. Clinical research data show that the combination antibody of alpaloritovorelli is safe, controllable and tolerable in patients with solid tumors, and has shown encouraging efficacy in cervical cancer and other multiple tumors. Based on the results of DUBHE-C-206 trial, the combination antibody was approved by the China food and Drug Administration on September 30 of 2024, and the phase I safety test has been completed in the United States.
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).
- Being tested
- Pulsed low dose rate radiotherapy (PLDR), Alpaloritovorelli antibodies
- Medical subject headings
- Esophageal Neoplasms, Carcinoma, Non-Small-Cell Lung, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulsed low dose rate radiotherapy (PLDR)Radiation
Radiation 5 times per week, 2Gy each time which divided into 10 pulse doses, each pulse interval was 3 minutes, the dose rate was 0.067 Gy/min, and each treatment time was 30 minutes.
Alpaloritovorelli antibodiesDrug
PLDR external irradiation therapy was administered simultaneously with 5mg/kg Alpaloritovorelli antibodies for a 3-week regimen, the following maintenance treatment was 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Pulsed low dose rate radiotherapy (PLDR) combined with Alpaloritovorelli antibodies (QL-1706)) | Experimental | Not described Receives: Radiation: Pulsed low dose rate radiotherapy (PLDR); Drug: Alpaloritovorelli antibodies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The proportion of patients whose tumor volume shrinks by 30% and can be maintained for more than four weeks, which is the sum of complete remission and partial remission (CR+PR).
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start1 Dec 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06760676
- Sponsor's protocol ID
- Zhou peijie 2024-ky-02
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 7 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06760676
- Acronym / sponsor ID
- Zhou peijie 2024-ky-02
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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. PLDR technology was first proposed by Tom é et al in 2007, and was first applied to the re-radiotherapy of recurrent tumors by Richards and Charlie Ma et al. The primary principle is the low-dose high radiosensitivity (HRS) of radiobiology, that is, a certain low-dose level of radiotherapy can increase the radiosensitivity of tumor cells and reduce the toxicity of normal tissues at the same time.
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. The combination antibody can maintain normal PD-1 antibody exposure in vivo and reduce the half-life of CTLA-4 antibody with lower toxicity and better tolerance. At present, sufficient preclinical studies of alpaloritovorelli antibodies have been completed, and a number of clinical studies are under way. The mechanism of action, safe dose range, mode of administration, toxicity characteristics and pharmacological characteristics are clear. Clinical research data show that the combination antibody of alpaloritovorelli is safe, controllable and tolerable in patients with solid tumors, and has shown encouraging efficacy in cervical cancer and other multiple tumors. Based on the results of DUBHE-C-206 trial, the combination antibody was approved by the China food and Drug Administration on September 30 of 2024, and the phase I safety test has been completed in the United States.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulsed low dose rate radiotherapy (PLDR) combined with Alpaloritovorelli antibodies (QL-1706)) | Experimental | Radiation: Pulsed low dose rate radiotherapy (PLDR), Drug: Alpaloritovorelli antibodies |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (23 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulsed low dose rate radiotherapy (PLDR)Radiation 5 times per week, 2Gy each time which divided into 10 pulse doses, each pulse interval was 3 minutes, the dose rate was 0.067 Gy/min, and each treatment time was 30 minutes. | Radiation | Pulsed low dose rate radiotherapy (PLDR) combined with Alpaloritovorelli antibodies (QL-1706)) |
| Alpaloritovorelli antibodiesPLDR external irradiation therapy was administered simultaneously with 5mg/kg Alpaloritovorelli antibodies for a 3-week regimen, the following maintenance treatment was 2 years. | Drug | Pulsed low dose rate radiotherapy (PLDR) combined with Alpaloritovorelli antibodies (QL-1706)) |
Primary outcome
Objective response rate (ORR)
Time frame: 6-12 months
The proportion of patients whose tumor volume shrinks by 30% and can be maintained for more than four weeks, which is the sum of complete remission and partial remission (CR+PR).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pulsed low dose rate radiotherapy (PLDR) and Alpaloritovorelli antibodies in people with Esophageal Cancer and Non Small Cell Lung Cancer, run by Anhui Provincial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pei jie Zhou, M.D. (+8618356148326, zhpejie@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: 6-12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2025.