About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Controlled Type 1 diabetes

Trial design

Design model

Single group

Treatments tested in this trial

Spatially Fractionated Radiation Therapy Followed by Sequential Hypofractionated or Conventional Fractionated Radiotherapy Combined with Iparomlimab and Tuvonralimab
Combination 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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Radiotherapy Combined with ImmunotherapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety (treatment-related toxicity and adverse reactions)

Adverse events (treatment toxicity) will be evaluated using NCI-CTCAE version 5.0.

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

Secondary outcomes

1

Complete Response (CR) rate

Complete Response (CR) rate assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

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.

2

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.

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.

3

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.

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.

4

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.

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.

SFRT+Sequential Hypofractionated/Conventional Fractionated RT+Iparomlimab and Tuvonralimab for Relapsed/Refractory Solid Tumors

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts