CancerPhase 2NCT06936748
SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors
A Phase 2 study testing Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and Tuvonralimab in people with Cancer, run by Second Affiliated Hospital of Nanchang University at 1 site in China.
Trial summary
Study Objectives Primary Objective:To evaluate the safety of SFRT followed by hypofractionated/conventional fractionated radiotherapy combined with Iparomlimab and Tuvonralimab Injection in relapsed/refractory bulky solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cancer
- What is being tested?
- Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and Tuvonralimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Jun 2025to 19 Jun 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years, male or female.
- Histologically confirmed malignant tumor in the past.
- Disease recurrence after treatment, including local regional relapsed and distant metastasis.
- At least one measurable lesion with a maximum diameter greater than 6 cm, unsuitable for conventional surgery, ablation, or other treatments.
- ECOG: 0-2 points.
- Expected survival ≥3 months.
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- Washout period of previous anti-tumor treatment >4 weeks.
- The patient agrees and signs the informed consent form.
- The function of vital organs meets the following requirements (no use of any blood components, cell growth factors, leukocyte boosters, platelet boosters, or anemia correction drugs within 14 days prior to the first use of the study drug):
- Absolute neutrophil count (ANC) ≥1.5×10^9/L;
- Platelets ≥90×10^9/L;
- Hemoglobin ≥8g/dL;
- Serum albumin ≥2.8g/dL;
- Total bilirubin ≤1.5×ULN, ALT, AST, and/or AKP ≤2.5×ULN; if liver metastasis is present, ALT and/or AST ≤5×ULN; if liver or bone metastasis is present, AKP ≤5×ULN;
- Serum creatinine ≤1.5×ULN or creatinine clearance rate greater than 60 mL/min;
- Activated partial thromboplastin time (APTT) and international normalized ratio (INR) ≤1.5×ULN (patients on stable doses of anticoagulation therapy such as low molecular weight heparin or warfarin with INR within the expected therapeutic range can be screened).
- Negative pregnancy test for female subjects (for female patients of childbearing potential);
- The subject voluntarily joins the study, signs the informed consent form, has good compliance, and cooperates with follow-up;
- The investigator believes that the patient may benefit.
Who cannot join
- History of severe immediate hypersensitivity reaction to any of the drugs used in this study.
- Any of the following conditions within 6 months prior to screening: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. Patients known to have coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on an optimized stable medical regimen as determined by the treating physician; consultation with a cardiologist may be appropriate if necessary.
- History of receiving anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug.
- Active autoimmune diseases or history of autoimmune diseases that may recur. However, patients with the following conditions are not excluded and can proceed to further screening:
- Controlled Type 1 diabetes
- Hypothyroidism (if it can be controlled with hormone replacement therapy alone)
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- Skin conditions that do not require systemic therapy (e.g., vitiligo, psoriasis, alopecia)
- Any other condition not expected to recur without external triggering factors
- Lack of civil capacity or limited civil capacity.
- Physical or mental conditions that impair the patient's ability to fully or adequately understand the potential complications of this study, as judged by the investigator.
- Patients with an expected survival of less than 3 months.
- Patients with significantly diminished cardiac, hepatic, pulmonary, renal, and bone marrow function.
- Drug abuse or alcohol addiction.
- Tumor lesions invading major blood vessels such as the internal carotid artery and vein and their major branches, posing a high risk of bleeding.
- Subjects requiring systemic treatment with corticosteroids (more than 10mg/day prednisone equivalent dose) or other immunosuppressive agents within 2 weeks prior to the first use of the investigational drug, except for the use of corticosteroids for local esophageal inflammation and prevention of allergies and nausea/vomiting. Special cases need to be discussed with the sponsor. In the absence of active autoimmune disease, inhaled or topical steroids and adrenal corticosteroid replacements at doses >10mg/day prednisone equivalent are allowed.
- History of immunodeficiency, including HIV-positive status, or other acquired or congenital immunodeficiency disorders, or history of organ transplantation or allogeneic bone marrow transplantation.
- Pregnant or breastfeeding female patients, male or female patients of childbearing potential who are unwilling or unable to use contraception for at least 1 year after the end of the treatment protocol throughout the study period.
- The investigator deems the patient unsuitable for inclusion.
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
The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Anwen Liu, Ph.D., +8613767120022, awliu666@163.com
About this study
Official title: A Study of Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated RT Combined With Iparomlimab and Tuvonralimab for Relapsed and Refractory Bulky Solid Tumors
Study Objectives Primary Objective:To evaluate the safety of SFRT followed by hypofractionated/conventional fractionated radiotherapy combined with Iparomlimab and Tuvonralimab Injection in relapsed/refractory bulky solid tumors.
Secondary Objectives:To assess efficacy (objective response rate, disease control rate, progression-free survival, etc.) and identify predictive biomarkers.To explore correlations between immunologic biomarkers (e.g., PD-L1 expression, plasma IL-2/IL-10) and treatment outcomes.
Study Endpoints Primary: Safety (incidence/severity of treatment-related adverse events).
Secondary:
ORR, DCR, DoR, mPFS, mOS Exploratory: Biomarker analysis (PD-L1, IL-2, IL-10).
Read the detailed description
- Study Title A Study of Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated RT Combined with Iparomlimab and Tuvonralimab for Relapsed and Refractory Bulky Solid Tumors
- Study Objectives Primary Objective: To evaluate the safety of SFRT followed by hypofractionated/Conventional Fractionated radiotherapy combined with Iparomlimab and Tuvonralimab in relapsed/refractory bulky solid tumors. Secondary Objectives: To assess efficacy (objective response rate, disease control rate, progression-free survival, etc.) and identify predictive biomarkers.To explore correlations between immunologic biomarkers (e.g., PD-L1 expression, plasma IL-2/IL-10) and treatment outcomes.
- Study Design Type: Prospective, single-arm, open-label, single-center clinical study. Target Population: Patients with relapsed/refractory bulky solid tumors (≥6 cm in diameter). Sample Size: 30 participants (based on primary safety endpoint).
- Patient Selection Inclusion Criteria: Age 18-75 years. Histologically confirmed malignancy with post-treatment recurrence (local or metastatic). At least one measurable lesion (>6 cm) unsuitable for surgery/ablation. ECOG performance status 0-2; life expectancy ≥3 months. Adequate organ function (within 14 days prior to enrollment): ANC ≥1.5×10⁹/L; platelets ≥90×10⁹/L; hemoglobin ≥8 g/dL. Serum albumin ≥2.8 g/dL; total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN with liver metastases). Creatinine ≤1.5×ULN or CrCl ≥60 mL/min. INR/APTT ≤1.5×ULN (stable anticoagulation allowed). Negative pregnancy test (for women of childbearing potential). Willingness to comply with protocol and provide informed consent. Exclusion Criteria: Severe hypersensitivity to study drugs. History of cardiovascular events (e.g., myocardial infarction, stroke) within 6 months. Active autoimmune disease (exceptions: controlled type 1 diabetes, hypothyroidism, localized skin conditions). Immunodeficiency (e.g., HIV, organ transplant). Systemic corticosteroids (>10 mg prednisone equivalent/day) within 2 weeks prior to treatment. Pregnancy, lactation, or refusal to use contraception. Other conditions deemed unsuitable by the investigator.
- Treatment Protocol
Radiotherapy Phase:
SFRT: 10-20 Gy/1 fraction to the tumor. Sequential Radiotherapy:Hypofractionated Radiotherapy: 20-70 Gy total (3-12.5 Gy/fraction) or Conventional Radiotherapy: 50-70 Gy total (1.8-2.5 Gy/fraction).Dose determined by investigator.
Immunotherapy Phase:
Iparomlimab and Tuvonralimab:
Dose: 5 mg/kg IV every 3 weeks (Day 1). Infusion: Diluted in 100 mL saline/5% glucose, administered over 20-60 minutes. Duration: Until disease progression, intolerable toxicity, new antitumor therapy, or up to 1 year.
Progression Management: Continuation post-progression permitted after investigator-patient discussion; permanent discontinuation upon re-progression.
- Study Endpoints
- Primary Endpoint(s) \& Definitions Safety Evaluation: Adverse events (treatment-related toxicities) assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
- Secondary Endpoints \& Definitions
- Complete Response (CR) Rate: Defined as the proportion of patients achieving complete response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Objective Response Rate (ORR): The proportion of patients achieving a reduction in tumor size meeting predefined criteria (Complete Response [CR]: disappearance of all target lesions; Partial Response [PR]: ≥30% reduction in the sum of target lesion diameters) per RECIST V1.1, sustained for a minimum duration.
- Disease Control Rate (DCR): Defined as the proportion of patients achieving tumor response (partial response [PR] + complete response [CR]) or stable disease (SD) per RECIST v1.1, sustained for a minimum required duration.
- Duration of Response (DoR): The time from achieving an objective response (CR or PR) to disease progression or recurrence. For example, in lung cancer targeted therapy trials, DoR measures the interval from achieving PR to tumor regrowth or new lesion development.
- Median Progression-Free Survival (mPFS): Defined as the median time from treatment initiation to the first documented disease progression or death from any cause, whichever occurs first.
- Median Overall Survival (mOS): Defined as the median time from treatment initiation to death from any cause. 7.Statistical Analysis Descriptive statistics for demographics, efficacy, and safety data. Kaplan-Meier method for survival analysis (mOS, mPFS). 95% confidence intervals for response rates. AE reporting: Incidence, severity, causality, and outcomes.
- Conditions
- Cancer
- Being tested
- Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and Tuvonralimab
- Keywords
- Bulky Solid Tumors, Spatially Fractionated Radiation Therapy, Immunotherapy, Iparomlimab and Tuvonralimab
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and TuvonralimabCombination product
Radiotherapy Phase: Spatially fractionated radiotherapy (SFRT, 10-20 Gy/1F) to the tumor, followed by hypofractionated/conventional fractionated radiotherapy (dose investigator-determined).
Immunotherapy Phase: Iparomlimab and Tuvonralimab (5 mg/kg) initiated within 1 week post-radiotherapy, infused IV over 20-60 minutes (Day 1, every 3 weeks) in 100 mL saline/5% glucose. Treatment continues until disease progression, intolerable toxicity, new antitumor therapy, consent withdrawal, or investigator decision, with a maximum duration of 1 year. Progression may allow continued therapy after patient-investigator discussion; re-progression mandates permanent discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Radiotherapy Combined with Immunotherapy | Experimental | This is a single-arm study. Treatment Protocol Radiotherapy Phase: SFRT: 10-20 Gy/1 fraction to the tumor. Sequential Radiotherapy:Hypofractionated Radiotherapy: 20-70 Gy total (3-12.5 Gy/fraction) or Conventional Fractionated Radiotherapy: 50-70 Gy total (1.8-2.5 Gy/fraction).Dose determined by investigator. Immunotherapy Phase: Iparomlimab and Tuvonralimab: Dose: 5 mg/kg IV every 3 weeks (Day 1). Infusion: Diluted in 100 mL saline/5% glucose, administered over 20-60 minutes. Duration: Until disease progression, intolerable toxicity, new antitumor therapy, or up to 1 year. Progression Management: Continuation post-progression permitted after investigator-patient discussion; permanent discontinuation upon re-progression. Receives: Combination Product: Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and Tuvonralimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (treatment-related toxicity and adverse reactions)
Adverse events (treatment toxicity) will be evaluated using NCI-CTCAE version 5.0.
Measured: The safety endpoints will be assessed by a review of adverse events and serious adverse events according to CTCAE up to 1 year after end of treatment
Secondary outcomes (6)
Complete Response (CR) rate
Complete Response (CR) rate assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
Measured: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Duration of Response (DoR)
Duration of Response (DoR) refers to the time from when a patient first achieves a complete response or partial response until disease progression or death due to any cause.
Measured: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Objective Response Rate (ORR)
Objective Response Rate (ORR) refers to the proportion of patients who achieve a best overall response of complete or partial response according to the RECIST 1.1 criteria.
Measured: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Median Progression-Free Survival (mPFS)
Median Progression-Free Survival (mPFS) refers to the median time from the start of treatment until the first discovery of disease progression or death due to any cause, whichever occurs first.
Measured: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Disease Control Rate (DCR)
Disease Control Rate (DCR) refers to the proportion of patients who achieve a response of partial response (PR) or complete response (CR) and those who have stable disease (SD) lasting for at least a minimum duration requirement, as per the RECIST 1.1 criteria for solid tumors.
Measured: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Median Overall Survival (mOS)
Median Overall Survival (mOS) refers to the median time from the start of treatment until death due to any cause.
Measured: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start20 Jun 2025
- Primary completion19 Jun 2028 (estimated)
- Study completion19 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Nanchang UniversityThe 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
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Anwen Liu, Ph.D., Principal investigator, Second Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936748
- Sponsor's protocol ID
- IIT-I-2025-014
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2025
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated RT Combined With Iparomlimab and Tuvonralimab for Relapsed and Refractory Bulky Solid Tumors
- ClinicalTrials.gov ID
- NCT06936748
- Acronym / sponsor ID
- IIT-I-2025-014
- Conditions
- Cancer
- Keywords
- Bulky Solid Tumors, Spatially Fractionated Radiation Therapy, Immunotherapy, Iparomlimab and Tuvonralimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Nanchang UniversityUniversity, hospital or other
- Collaborators
- Qilu Pharmaceutical Co., Ltd.
- Study start
- 20 Jun 2025 (actual)
- Primary completion
- 19 Jun 2028 (estimated)
- Study completion
- 19 Jun 2029 (estimated)
- First posted
- 20 Apr 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.
Study Objectives Primary Objective:To evaluate the safety of SFRT followed by hypofractionated/conventional fractionated radiotherapy combined with Iparomlimab and Tuvonralimab Injection in relapsed/refractory bulky solid tumors.
Secondary Objectives:To assess efficacy (objective response rate, disease control rate, progression-free survival, etc.) and identify predictive biomarkers.To explore correlations between immunologic biomarkers (e.g., PD-L1 expression, plasma IL-2/IL-10) and treatment outcomes.
Study Endpoints Primary: Safety (incidence/severity of treatment-related adverse events).
Secondary:
ORR, DCR, DoR, mPFS, mOS Exploratory: Biomarker analysis (PD-L1, IL-2, IL-10).
Detailed description
- Study Title A Study of Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated RT Combined with Iparomlimab and Tuvonralimab for Relapsed and Refractory Bulky Solid Tumors
- Study Objectives Primary Objective: To evaluate the safety of SFRT followed by hypofractionated/Conventional Fractionated radiotherapy combined with Iparomlimab and Tuvonralimab in relapsed/refractory bulky solid tumors. Secondary Objectives: To assess efficacy (objective response rate, disease control rate, progression-free survival, etc.) and identify predictive biomarkers.To explore correlations between immunologic biomarkers (e.g., PD-L1 expression, plasma IL-2/IL-10) and treatment outcomes.
- Study Design Type: Prospective, single-arm, open-label, single-center clinical study. Target Population: Patients with relapsed/refractory bulky solid tumors (≥6 cm in diameter). Sample Size: 30 participants (based on primary safety endpoint).
- Patient Selection Inclusion Criteria: Age 18-75 years. Histologically confirmed malignancy with post-treatment recurrence (local or metastatic). At least one measurable lesion (>6 cm) unsuitable for surgery/ablation. ECOG performance status 0-2; life expectancy ≥3 months. Adequate organ function (within 14 days prior to enrollment): ANC ≥1.5×10⁹/L; platelets ≥90×10⁹/L; hemoglobin ≥8 g/dL. Serum albumin ≥2.8 g/dL; total bilirubin ≤1.5×ULN; ALT/AST ≤2.5×ULN (≤5×ULN with liver metastases). Creatinine ≤1.5×ULN or CrCl ≥60 mL/min. INR/APTT ≤1.5×ULN (stable anticoagulation allowed). Negative pregnancy test (for women of childbearing potential). Willingness to comply with protocol and provide informed consent. Exclusion Criteria: Severe hypersensitivity to study drugs. History of cardiovascular events (e.g., myocardial infarction, stroke) within 6 months. Active autoimmune disease (exceptions: controlled type 1 diabetes, hypothyroidism, localized skin conditions). Immunodeficiency (e.g., HIV, organ transplant). Systemic corticosteroids (>10 mg prednisone equivalent/day) within 2 weeks prior to treatment. Pregnancy, lactation, or refusal to use contraception. Other conditions deemed unsuitable by the investigator.
- Treatment Protocol
Radiotherapy Phase:
SFRT: 10-20 Gy/1 fraction to the tumor. Sequential Radiotherapy:Hypofractionated Radiotherapy: 20-70 Gy total (3-12.5 Gy/fraction) or Conventional Radiotherapy: 50-70 Gy total (1.8-2.5 Gy/fraction).Dose determined by investigator.
Immunotherapy Phase:
Iparomlimab and Tuvonralimab:
Dose: 5 mg/kg IV every 3 weeks (Day 1). Infusion: Diluted in 100 mL saline/5% glucose, administered over 20-60 minutes. Duration: Until disease progression, intolerable toxicity, new antitumor therapy, or up to 1 year.
Progression Management: Continuation post-progression permitted after investigator-patient discussion; permanent discontinuation upon re-progression.
- Study Endpoints
- Primary Endpoint(s) \& Definitions Safety Evaluation: Adverse events (treatment-related toxicities) assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 5.0.
- Secondary Endpoints \& Definitions
- Complete Response (CR) Rate: Defined as the proportion of patients achieving complete response per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
- Objective Response Rate (ORR): The proportion of patients achieving a reduction in tumor size meeting predefined criteria (Complete Response [CR]: disappearance of all target lesions; Partial Response [PR]: ≥30% reduction in the sum of target lesion diameters) per RECIST V1.1, sustained for a minimum duration.
- Disease Control Rate (DCR): Defined as the proportion of patients achieving tumor response (partial response [PR] + complete response [CR]) or stable disease (SD) per RECIST v1.1, sustained for a minimum required duration.
- Duration of Response (DoR): The time from achieving an objective response (CR or PR) to disease progression or recurrence. For example, in lung cancer targeted therapy trials, DoR measures the interval from achieving PR to tumor regrowth or new lesion development.
- Median Progression-Free Survival (mPFS): Defined as the median time from treatment initiation to the first documented disease progression or death from any cause, whichever occurs first.
- Median Overall Survival (mOS): Defined as the median time from treatment initiation to death from any cause. 7.Statistical Analysis Descriptive statistics for demographics, efficacy, and safety data. Kaplan-Meier method for survival analysis (mOS, mPFS). 95% confidence intervals for response rates. AE reporting: Incidence, severity, causality, and outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiotherapy Combined with Immunotherapy | Experimental | Combination Product: Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and TuvonralimabThis is a single-arm study. Treatment Protocol Radiotherapy Phase: SFRT: 10-20 Gy/1 fraction to the tumor. Sequential Radiotherapy:Hypofractionated Radiotherapy: 20-70 Gy total (3-12.5 Gy/fraction) or Conventional Fractionated Radiotherapy: 50-70 Gy total (1.8-2.5 Gy/fraction).Dose determined by investigator. Immunotherapy Phase: Iparomlimab and Tuvonralimab: Dose: 5 mg/kg IV every 3 weeks (Day 1). Infusion: Diluted in 100 mL saline/5% glucose, administered over 20-60 minutes. Duration: Until disease progression, intolerable toxicity, new antitumor therapy, or up to 1 year. Progression Management: Continuation post-progression permitted after investigator-patient discussion; permanent discontinuation upon re-progression. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Age 18-75 years, male or female.
- Histologically confirmed malignant tumor in the past.
- Disease recurrence after treatment, including local regional relapsed and distant metastasis.
- At least one measurable lesion with a maximum diameter greater than 6 cm, unsuitable for conventional surgery, ablation, or other treatments.
- ECOG: 0-2 points.
Key exclusion criteria (18 listed)
- History of severe immediate hypersensitivity reaction to any of the drugs used in this study.
- Any of the following conditions within 6 months prior to screening: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, or symptomatic pulmonary embolism. Patients known to have coronary artery disease, congestive heart failure not meeting the above criteria, or left ventricular ejection fraction <50% must be on an optimized stable medical regimen as determined by the treating physician; consultation with a cardiologist may be appropriate if necessary.
- History of receiving anti-tumor vaccines or live vaccines within 4 weeks prior to the first dose of the investigational drug.
- Active autoimmune diseases or history of autoimmune diseases that may recur. However, patients with the following conditions are not excluded and can proceed to further screening:
- Lack of civil capacity or limited civil capacity.
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 |
|---|---|---|
| Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and TuvonralimabRadiotherapy Phase: Spatially fractionated radiotherapy (SFRT, 10-20 Gy/1F) to the tumor, followed by hypofractionated/conventional fractionated radiotherapy (dose investigator-determined). Immunotherapy Phase: Iparomlimab and Tuvonralimab (5 mg/kg) initiated within 1 week post-radiotherapy, infused IV over 20-60 minutes (Day 1, every 3 weeks) in 100 mL saline/5% glucose. Treatment continues until disease progression, intolerable toxicity, new antitumor therapy, consent withdrawal, or investigator decision, with a maximum duration of 1 year. Progression may allow continued therapy after patient-investigator discussion; re-progression mandates permanent discontinuation. | Combination product | Radiotherapy Combined with Immunotherapy |
Primary outcome
Safety (treatment-related toxicity and adverse reactions)
Time frame: The safety endpoints will be assessed by a review of adverse events and serious adverse events according to CTCAE up to 1 year after end of treatment
Adverse events (treatment toxicity) will be evaluated using NCI-CTCAE version 5.0.
6 secondary outcomes
Complete Response (CR) rate
Time frame: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Duration of Response (DoR)
Time frame: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Objective Response Rate (ORR)
Time frame: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Median Progression-Free Survival (mPFS)
Time frame: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Disease Control Rate (DCR)
Time frame: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
Median Overall Survival (mOS)
Time frame: One imageological examination will be performed during the baseline period, followed by another imageological examination after the completion of radiotherapy. During immunotherapy, imaging assessments will be conducted every 3 treatment cycles.
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 5 May 2026.
- Individual participant dataSharing planned: No
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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.
Anwen Liu, Ph.D. principal investigator
Second Affiliated Hospital of Nanchang University
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 Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and Tuvonralimab in people with Cancer, run by Second Affiliated Hospital of Nanchang University 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 19 inclusion and 18 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 5 May 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?
Contact Anwen Liu, Ph.D. (+8613767120022, awliu666@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (treatment-related toxicity and adverse reactions) (time frame: The safety endpoints will be assessed by a review of adverse events and serious adverse events according to CTCAE up to 1 year after end of treatment). 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 5 May 2026.