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Taking people in ChinaPhase 2

Tests lattice radiation therapy combined with immunotherapy for advanced solid tumors

Tests lattice radiation with immunotherapy in adults with advanced solid tumors.

Key facts

Who runs it
Tianjin Medical University Cancer Institute and Hospital
Where
Beijing, Cangzhou, and Tianjin, ChinaSee the 3 sites
Trial code
Registry title
Spatially Fractionated Radiotherapy Combined With Immunotherapy for Advanced Solid Tumors
Status
Recruiting
Phase
Phase 2
People taking part
30 people, planned
Started
1 Jul 2025
Expected to end
1 Jul 2027
Type of study
Interventional
Treatments tested
  • lattice radiation therapy
Record updated
29 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with an advanced solid tumor that cannot be treated with surgery and has no standard treatment left. They will get lattice radiotherapy together with immunotherapy.

Age
18 years or older
Sex
All sexes can join
Disease stage
Advanced solid tumor confirmed by tissue or cell tests, not able to have surgery. At least one measurable lesion. Disease stable or progressing. Life expectancy over 3 months. KPS score of 70 or more.
Earlier treatment
No standard treatment available, or the person cannot tolerate it. No earlier radiotherapy to the planned site, or the last one at least 6 months ago. Side effects of earlier treatment must have eased to grade 1 or baseline.

Main reasons for not taking part

  • Active brain or spinal cord metastases, or carcinomatous meningitis
  • Interstitial lung disease, active pneumonia needing steroids, or pulmonary fibrosis
  • Active or suspected autoimmune disease (some exceptions)
  • Earlier allogeneic organ or stem cell transplant (except cornea)
  • Pregnant or breastfeeding women

The registry criteria, word for word

Show all 27 criteriaShow less

Other criteria

  • **Inclusion Criteria:**
  • Signed informed consent
  • Histologically or cytologically confirmed malignant solid tumor
  • Advanced solid tumor unsuitable for surgery as determined by a multidisciplinary tumor board or consulting physicians
  • No available standard therapy or inability to tolerate it, with imaging and clinical assessment showing stable disease (SD) or progressive disease (PD)
  • Age ≥18 years on the day of signing informed consent
  • No prior radiotherapy to the proposed site, or last radiotherapy ≥6 months ago
  • KPS score ≥70
  • At least one measurable lesion per RECIST 1.1. Previously irradiated lesions qualify only if significant progression post - radiotherapy
  • Life expectancy >3 months
  • Adequate organ and bone marrow function:; Marrow: ANC ≥1.5×10⁹/L, platelets ≥80×10⁹/L, hemoglobin ≥9 g/dL; Liver: Total bilirubin ≤1.5× upper limit of normal (ULN), ALT/AST ≤1.5× ULN; Kidney: Serum creatinine ≤1.5× ULN or creatinine clearance ≥50 ml/min, blood urea nitrogen ≤200 mg/L; Coagulation: INR ≤1.5× ULN, PTT ≤1.5× ULN
  • Recovery from prior therapy - related adverse events (≤Grade 1 or baseline)
  • Willingness to use appropriate contraception
  • No radiotherapy contraindications as judged by the radiation oncologist
  • Agreement to receive both immunotherapy and radiotherapy; **Exclusion Criteria:**
  • Active central nervous system (CNS) metastases, carcinomatous meningitis, or spinal cord compression
  • Severe comorbidities such as myocardial infarction within 6 months, severe arrhythmias, or psychosis that may affect treatment completion or result in a life expectancy of <3 months
  • Evidence of interstitial lung disease or active/non - infectious pneumonia (e.g., drug - induced, radiation - induced) requiring steroid treatment
  • History of pulmonary fibrosis, pulmonary artery hypertension, or severe irreversible airway obstruction
  • Presence of peripheral neuropathy
  • Severe organ dysfunction (e.g., hepatic, cardiopulmonary failure) that is likely to make radiotherapy intolerable
  • Known allergy to study drugs or excipients, or a history of severe allergic reaction to any PD - 1 monoclonal antibody
  • Serious infection within 4 weeks prior to the start of study treatment, including but not limited to hospitalization for infection, bacteremia, or severe pneumonia; or receipt of oral or intravenous antibiotics within 2 weeks prior to study treatment. Patients receiving prophylactic antibiotics (e.g., for urinary tract infections or chronic obstructive pulmonary disease exacerbations) are eligible
  • Known or suspected active autoimmune disease (e.g., uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, thyroiditis). Exceptions: patients with vitiligo, cured childhood asthma; patients with well - controlled type 1 diabetes on insulin
  • History of allogeneic organ transplant (except corneal) or allogeneic hematopoietic stem cell transplant
  • Pregnant or breastfeeding women
  • Any other condition that the investigator deems a valid reason for disqualification based on the protocol

Where in China

  • Beijing Friendship Hospital, Capital Medical UniversityBeijing, ChinaContact: Jing Yu Pro, DoctorTaking people
  • Hebei Province Cangzhou Hospital of Integrated Traditional and Western MedicineCangzhou, ChinaContact: Yunchuan Sun Pro, DoctorTaking people
  • Tianjin Medical University Cancer Institute & HospitalTianjin, ChinaContact: Ningbo LiuTaking people

About the trial

What the trial wants to find out

Lattice radiation therapy (LRT) is a spatially fractionated radiotherapy technique that creates alternating high - and low - dose areas within a tumor to enhance local control and reduce toxicity to surrounding tissues. This study aims to evaluate the effectiveness and safety of combining LRT with immunotherapy in patients with advanced or metastatic solid tumors, through a Phase II clinical trial. Patients will receive specific - dose irradiation using a medical linear accelerator. Within the GTV of the largest tumor, spheres (0.5 - 3 cm in diameter) will be created as high - dose targets (LRT targets), spaced 2.0 - 5.0 cm apart. The LRT targets must be drawn within the GTV, avoiding blood vessels, with a margin of at least 1 cm from the GTV margin, and a volume ratio of 1% - 10% of the GTV. For a single lesion, the D95 of the GTV will be ≥1 Gy/fraction, and the D95 of the LRT target will be 8 - 12 Gy/fraction, with minimal possible single - fraction doses to organs at risk. All other irradiated metastases will receive low - dose radiotherapy (100 - 300 cGy × 5 fractions), except for brain and bone metastases, which will be treated with palliative radiotherapy as per clinical routine. Immunotherapy will be administered during or within one week after radiotherapy.

The group in the trial

  • experimental groupTreatment being tested

    Eligible patients in this Phase II trial will undergo specific - dose irradiation using a medical linear accelerator. Within the largest tumor's gross tumor volume (GTV), spheres (0.5 - 3 cm in diameter) will be created as high - dose targets (LRT targets), spaced 2.0 - 5.0 cm apart. The LRT targets must be drawn within the GTV, avoiding blood vessels, with a margin of at least 1 cm from the GTV edge and a volume ratio of 1% - 10% of the GTV. For a single lesion, the D95 of the GTV will be ≥1 Gy per fraction, and the D95 of the LRT target will be 8 - 12 Gy per fraction, while keeping the single - fraction dose to organs at risk as low as possible. All other irradiated metastases will receive low - dose radiotherapy at 100 - 300 cGy × 5 fractions. Brain and bone metastases will be treated with palliative radiotherapy as per clinical routine and are not included in the low - dose radiotherapy. Immunotherapy will be administered during or within one week after radiotherapy.

    Treatment: lattice radiation therapy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase II Prospective, Open-Label, Single-Arm Study Evaluating the Efficacy and Safety of Spatially Fractionated Radiotherapy Combined With Immunotherapy in Patients With Advanced Solid Tumors
Plain-language title
Tests lattice radiation therapy combined with immunotherapy for advanced solid tumorsGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
29 April 2026