Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT06936748

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

Led by Second Affiliated Hospital of Nanchang University · Updated on 2026-05-05

30

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital of Nanchang University

Lead Sponsor

Q

Qilu Pharmaceutical Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 75 years, male or female
  • Histologically confirmed malignant tumor
  • Disease recurrence after treatment, including local or distant relapse
  • At least one measurable lesion larger than 6 cm, unsuitable for surgery or ablation
  • ECOG performance status between 0 and 2
  • Expected survival of at least 3 months
  • More than 4 weeks since last anti-tumor treatment
  • Willing and able to sign informed consent
  • Adequate organ function within 14 days prior to enrollment, including specific blood counts, liver and kidney function, and coagulation parameters
  • Negative pregnancy test for women of childbearing potential
  • Good compliance and cooperation with follow-up
  • Investigator believes patient may benefit from the study
Not Eligible

You will not qualify if you...

  • Severe allergic reaction history to study drugs
  • Serious cardiovascular events within 6 months before screening
  • Anti-tumor or live vaccines received within 4 weeks before first study drug dose
  • Active or recurrent autoimmune diseases except controlled type 1 diabetes, hypothyroidism, or localized skin conditions
  • Lack of or limited civil capacity
  • Physical or mental conditions preventing understanding of study risks
  • Expected survival less than 3 months
  • Significantly impaired heart, liver, lung, kidney, or bone marrow function
  • Drug or alcohol addiction
  • Tumor invading major blood vessels with high bleeding risk
  • Use of systemic corticosteroids above 10 mg prednisone equivalent within 2 weeks prior to treatment, except for specified exceptions
  • History of immunodeficiency or organ/bone marrow transplantation
  • Pregnant or breastfeeding women or unwillingness to use contraception for 1 year post-treatment
  • Investigator deems patient unsuitable for inclusion

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330006

Actively Recruiting

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Research Team

A

Anwen Liu, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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