Advanced Malignant Solid TumorPhase 2NCT07865793
Clinical Study of Three-dimensional Lattice Radiotherapy Combined With PD-1/PD-L1 Inhibitors in the Treatment of Advanced Solid Tumors
A Phase 2 study testing lattice radiotherapy and PD-1/PD-L1 inhibitors in people with Advanced Malignant Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
Trial summary
This study aims to evaluate the safety and tolerability of lattice radiation therapy in combination with PD-1/PD-L1 inhibitors for patients with advanced solid tumors and large tumors, and to assess its efficacy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Malignant Solid Tumor
- What is being tested?
- lattice radiotherapy and PD-1/PD-L1 inhibitors
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteChina
- Study dates
- 25 Jun 2025to 1 Apr 2027
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1.1 age 18-80 years old, male or female; 1.2 the enrolled patients are advanced solid tumors with recurrence or metastasis (no limit to tumor species), tumor location is not limited (except for brain metastasis), with clear pathological diagnosis or clinical history, and at least one large tumor lesion that can be measured by imaging (single tumor diameter ≥ 5cm, volume 50cc~3000cc); 1.3 PD (progression) after using the first-line and above system treatment scheme (including chemotherapy, targeted or immunotherapy, etc.) recommended by the guidelines, or the patient cannot tolerate the first-line treatment scheme (chemotherapy, etc.); 1.4 biochemical indicators of important organs meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet ≥ 80 × 109/L; hemoglobin ≥ 80g/L; Serum albumin ≥ 28g/L; Total bilirubin ≤ 1.5 × Upper limit of normal value (ULN) , Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST) and/or Alkaline Phosphatase (AKP) ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60ml/min (calculated according to Cockcroft Gault formula); International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for anticoagulant therapy using a stable dose, such as low molecular weight heparin or warfarin, and INR can be screened within the expected treatment range of anticoagulants); 1.5 no congestive heart failure, unstable angina pectoris or unstable arrhythmia occurred in recent 6 months; 1.6 patients' activity status score was 0-2 points in the Eastern Cooperative Oncology Group (ECOG) score method or ≥ 70 points in the Karnofsky (KPS) score method, and ≥ 6 months in the life expectancy assessment; 1.7 no previous history of immune diseases; 1.8 patients voluntarily participate in the study, sign the informed consent, have the conditions for follow-up and are willing to adhere to the follow-up.
Who cannot join
- 2.1 patients with cavity organ metastasis; There are important nerves or blood vessels passing through the large tumor, which can not be avoided when placing lattice ball; 2.2 brain metastases; 2.3 for those who have a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the clinical severity may hinder the signing of informed consent or affect the patient's compliance with drug treatment according to the judgment of the investigator; 2.4 have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except for patients with vitiligo or cured asthma/allergy of the same age, who do not need any intervention after adulthood; Patients with autoimmune hypothyroidism treated with stable dose of thyroid hormone replacement therapy and type I diabetes treated with stable dose of insulin can be included; Adverse reactions of previous immunotherapy ≥ grade 2; 2.5 have a history of immune deficiency, including HIV test positive, or suffer from other acquired and congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation; 2.6 have uncontrollable cardiac clinical symptoms or diseases, such as (1) heart failure of NYHA II and above; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Subjects with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 2.7 severe infection (CTCAE>grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; The symptoms and signs of active pulmonary inflammation and infection within 2 weeks before the first use of the study drug in the baseline chest imaging examination require oral or intravenous antibiotic treatment, except for the use of prophylactic antibiotics; 2.8 patients with active pulmonary tuberculosis infection found by medical history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis infection history more than 1 year ago but without formal treatment; 2.9 the subjects had active hepatitis B (HBV DNA ≥ 2000 iu/ml or 104 copies/ml), hepatitis C (HCV antibody was positive, and HCV-RNA was higher than the detection limit of the analysis method); 2.10 there were abnormal laboratory test values of sodium, potassium and calcium greater than grade 1 within 2 weeks before enrollment, which could not be improved after treatment; 2.11 have been diagnosed as any other malignant tumor, except the malignant tumor with low risk of metastasis and death (5-year survival rate>90%), including but not limited to fully treated basal cell carcinoma or squamous cell skin carcinoma, cervical carcinoma in situ, breast carcinoma in situ and papillary thyroid carcinoma; 2.12 patients with KPS ≤ 60, extensive systemic metastasis, too large tumor load, or life expectancy ≤ 6 months. 2.13 according to the judgment of the investigator, the patient has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental diseases) and requiring combined treatment, recently having other serious diseases (such as myocardial infarction and cerebrovascular accident) and considering the high risk of recurrence, serious abnormal laboratory test values, family or social factors, which may affect the patient safety or the collection of test data.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
Shenzhen, Guangdong, 518172
Lining Chen, 0755-66618168-60512, chenlining2011@163.com
Qin Xiao, 0755-66618168-60511, xiaoqin@cicams-sz.org.cn
About this study
This study aims to evaluate the safety and tolerability of lattice radiation therapy in combination with PD-1/PD-L1 inhibitors for patients with advanced solid tumors and large tumors, and to assess its efficacy.
Read the detailed description
This study is for advanced solid tumors with recurrence or metastasis patients. Patients will receive lattice radiotherapy combined with PD-1/PD-L1 inhibitors. For large tumors, Lattice radiotherapy should be performed first (recommended 24Gy/8Gy/3f, 30Gy/10Gy/3f, 15Gy/15Gy/1f), with or without sequential conventional fractionated radiotherapy. The dose of sequential conventional fractionated radiotherapy mainly depends on the tumor size, actual condition, and OAR limit, for example: 20Gy/4Gy/5fx, 40-50Gy/2Gy/20-25fx. Receive PD-1/PD-L1 inhibitor Q3W combined or not combined with systemic drug therapy within one month after radiotherapy (the combination drug regimen is determined according to the guidelines for each tumor type or the medication regimen recommended by the oncology department consultation. For patients with immune dysfunction, immune enhancing drugs such as thymidine can be used) until disease progression or intolerable treatment toxicity occurs (up to one year).
- Conditions
- Advanced Malignant Solid Tumor
- Being tested
- lattice radiotherapy and PD-1/PD-L1 inhibitors
- Keywords
- lattice, radiotherapy, immunotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lattice radiotherapy and PD-1/PD-L1 inhibitorsCombination product
For large tumors, Lattice spatial segmentation radiotherapy should be performed first (recommended 24Gy/8Gy/3f, 30Gy/10Gy/3f, 15Gy/15Gy/1f), with or without sequential conventional segmentation radiotherapy. The dose of sequential conventional segmentation radiotherapy mainly depends on the tumor size, actual condition, and OAR limit, for example: 20Gy/4Gy/5fx, 40-50Gy/2Gy/20-25fx. Receive PD-1/PD-L1 inhibitor Q3W combined or not combined with systemic drug therapy within one month after radiotherapy (the combination drug regimen is determined according to the guidelines for each tumor type or the medication regimen recommended by the oncology department consultation. For patients with immune dysfunction, immune enhancing drugs such as thymidine can be used) until disease progression or intolerable treatment toxicity occurs (up to one year).
| Study group | Role | What they receive |
|---|---|---|
| Clinical study of three-dimensional lattice radiotherapy combined with PD-1/PD-L1 inhibitors in the | Experimental | Not described Receives: Combination Product: lattice radiotherapy and PD-1/PD-L1 inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start25 Jun 2025
- Primary completion25 Dec 2025
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865793
- Sponsor's protocol ID
- JS2025-8-1
- Status last verified
- Jul 2026
- First submitted
- 31 Mar 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Three-dimensional Lattice Radiotherapy Combined With PD-1/PD-L1 Inhibitors in the Treatment of Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07865793
- Acronym / sponsor ID
- JS2025-8-1
- Conditions
- Advanced Malignant Solid Tumor
- Keywords
- lattice, radiotherapy, immunotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 25 Dec 2025 (actual)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 8 Oct 2026 (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.
This study aims to evaluate the safety and tolerability of lattice radiation therapy in combination with PD-1/PD-L1 inhibitors for patients with advanced solid tumors and large tumors, and to assess its efficacy.
Detailed description
This study is for advanced solid tumors with recurrence or metastasis patients. Patients will receive lattice radiotherapy combined with PD-1/PD-L1 inhibitors. For large tumors, Lattice radiotherapy should be performed first (recommended 24Gy/8Gy/3f, 30Gy/10Gy/3f, 15Gy/15Gy/1f), with or without sequential conventional fractionated radiotherapy. The dose of sequential conventional fractionated radiotherapy mainly depends on the tumor size, actual condition, and OAR limit, for example: 20Gy/4Gy/5fx, 40-50Gy/2Gy/20-25fx. Receive PD-1/PD-L1 inhibitor Q3W combined or not combined with systemic drug therapy within one month after radiotherapy (the combination drug regimen is determined according to the guidelines for each tumor type or the medication regimen recommended by the oncology department consultation. For patients with immune dysfunction, immune enhancing drugs such as thymidine can be used) until disease progression or intolerable treatment toxicity occurs (up to one year).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clinical study of three-dimensional lattice radiotherapy combined with PD-1/PD-L1 inhibitors in the | Experimental | Combination Product: lattice radiotherapy and PD-1/PD-L1 inhibitors |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1.1 age 18-80 years old, male or female; 1.2 the enrolled patients are advanced solid tumors with recurrence or metastasis (no limit to tumor species), tumor location is not limited (except for brain metastasis), with clear pathological diagnosis or clinical history, and at least one large tumor lesion that can be measured by imaging (single tumor diameter ≥ 5cm, volume 50cc~3000cc); 1.3 PD (progression) after using the first-line and above system treatment scheme (including chemotherapy, targeted or immunotherapy, etc.) recommended by the guidelines, or the patient cannot tolerate the first-line treatment scheme (chemotherapy, etc.); 1.4 biochemical indicators of important organs meet the following requirements: absolute neutrophil count (ANC) ≥ 1.5 × 109/L; platelet ≥ 80 × 109/L; hemoglobin ≥ 80g/L; Serum albumin ≥ 28g/L; Total bilirubin ≤ 1.5 × Upper limit of normal value (ULN) , Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST) and/or Alkaline Phosphatase (AKP) ≤ 2.5 × ULN; Serum creatinine ≤ 1.5 × ULN or creatinine clearance rate ≥ 60ml/min (calculated according to Cockcroft Gault formula); International normalized ratio (INR) and activated partial thromboplastin time (APTT) ≤ 1.5 × ULN (for anticoagulant therapy using a stable dose, such as low molecular weight heparin or warfarin, and INR can be screened within the expected treatment range of anticoagulants); 1.5 no congestive heart failure, unstable angina pectoris or unstable arrhythmia occurred in recent 6 months; 1.6 patients' activity status score was 0-2 points in the Eastern Cooperative Oncology Group (ECOG) score method or ≥ 70 points in the Karnofsky (KPS) score method, and ≥ 6 months in the life expectancy assessment; 1.7 no previous history of immune diseases; 1.8 patients voluntarily participate in the study, sign the informed consent, have the conditions for follow-up and are willing to adhere to the follow-up.
Key exclusion criteria (1 listed)
- 2.1 patients with cavity organ metastasis; There are important nerves or blood vessels passing through the large tumor, which can not be avoided when placing lattice ball; 2.2 brain metastases; 2.3 for those who have a history of uncontrolled epilepsy, central nervous system disease or mental disorder, the clinical severity may hinder the signing of informed consent or affect the patient's compliance with drug treatment according to the judgment of the investigator; 2.4 have any active autoimmune disease or history of autoimmune disease (such as interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism); Except for patients with vitiligo or cured asthma/allergy of the same age, who do not need any intervention after adulthood; Patients with autoimmune hypothyroidism treated with stable dose of thyroid hormone replacement therapy and type I diabetes treated with stable dose of insulin can be included; Adverse reactions of previous immunotherapy ≥ grade 2; 2.5 have a history of immune deficiency, including HIV test positive, or suffer from other acquired and congenital immune deficiency diseases, or have a history of organ transplantation and allogeneic bone marrow transplantation; 2.6 have uncontrollable cardiac clinical symptoms or diseases, such as (1) heart failure of NYHA II and above; (2) Unstable angina pectoris; (3) Myocardial infarction occurred within 1 year; (4) Subjects with clinically significant supraventricular or ventricular arrhythmias requiring clinical intervention; 2.7 severe infection (CTCAE>grade 2) occurred within 4 weeks before the first use of the study drug, such as severe pneumonia, bacteremia, and infection complications requiring hospitalization; The symptoms and signs of active pulmonary inflammation and infection within 2 weeks before the first use of the study drug in the baseline chest imaging examination require oral or intravenous antibiotic treatment, except for the use of prophylactic antibiotics; 2.8 patients with active pulmonary tuberculosis infection found by medical history or CT examination, or patients with active pulmonary tuberculosis infection history within 1 year before enrollment, or patients with active pulmonary tuberculosis infection history more than 1 year ago but without formal treatment; 2.9 the subjects had active hepatitis B (HBV DNA ≥ 2000 iu/ml or 104 copies/ml), hepatitis C (HCV antibody was positive, and HCV-RNA was higher than the detection limit of the analysis method); 2.10 there were abnormal laboratory test values of sodium, potassium and calcium greater than grade 1 within 2 weeks before enrollment, which could not be improved after treatment; 2.11 have been diagnosed as any other malignant tumor, except the malignant tumor with low risk of metastasis and death (5-year survival rate>90%), including but not limited to fully treated basal cell carcinoma or squamous cell skin carcinoma, cervical carcinoma in situ, breast carcinoma in situ and papillary thyroid carcinoma; 2.12 patients with KPS ≤ 60, extensive systemic metastasis, too large tumor load, or life expectancy ≤ 6 months. 2.13 according to the judgment of the investigator, the patient has other factors that may cause him to be forced to terminate the study halfway, such as suffering from other serious diseases (including mental diseases) and requiring combined treatment, recently having other serious diseases (such as myocardial infarction and cerebrovascular accident) and considering the high risk of recurrence, serious abnormal laboratory test values, family or social factors, which may affect the patient safety or the collection of test data.
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 |
|---|---|---|
| lattice radiotherapy and PD-1/PD-L1 inhibitorsFor large tumors, Lattice spatial segmentation radiotherapy should be performed first (recommended 24Gy/8Gy/3f, 30Gy/10Gy/3f, 15Gy/15Gy/1f), with or without sequential conventional segmentation radiotherapy. The dose of sequential conventional segmentation radiotherapy mainly depends on the tumor size, actual condition, and OAR limit, for example: 20Gy/4Gy/5fx, 40-50Gy/2Gy/20-25fx. Receive PD-1/PD-L1 inhibitor Q3W combined or not combined with systemic drug therapy within one month after radiotherapy (the combination drug regimen is determined according to the guidelines for each tumor type or the medication regimen recommended by the oncology department consultation. For patients with immune dysfunction, immune enhancing drugs such as thymidine can be used) until disease progression or intolerable treatment toxicity occurs (up to one year). | Combination product | Clinical study of three-dimensional lattice radiotherapy combined with PD-1/PD-L1 inhibitors in the |
Primary outcome
Objective response rate
Time frame: 6 months
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 8 Oct 2026.
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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.
Chinese Academy of Medical Sciences Cancer Hospital Shenzhen Hospital
Shenzhen, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing lattice radiotherapy and PD-1/PD-L1 inhibitors in people with Advanced Malignant Solid Tumor, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 1 site in China.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (time frame: 6 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 8 Oct 2026.