Local Radiotherapy in Combination With Immunotherapy in Advanced Solid Tumors Patients

NCT05097781 | Unknown Phase 2

• 1 other identifier: RuijinHDR
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II study to observe efficacy of combining local radiotherapy with PD-1blockade in patients with advanced solid tumors. All patients will accept at least one site of radiotherapy together with PD-1 blockade. The study will evaluate changes of unirradiated and irradiated lesions.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Objective response rate

  The proportion of patients with a tumor volume reduction of 30% lasting for at least 4 weeks，and is the sum of the proportion of complete remission (CR) and partial remission (PR)

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed at least 4 weeks

• non-irradiated lesion control rate(NRCR)

  The percentage of non-irradiated target lesions with CR/PR or SD

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Secondary Outcomes (3)

• Progression free survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

• Overall survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

• Rate of side effects

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months

Study Arms (1)

Treatment arm

EXPERIMENTAL

Local irradiation + immunotherapy

Drug: PD-1 blocking antibody

Interventions

PD-1 blocking antibody DRUG

All patients with more than one distant metastatic lesions will accept at least one site of radiotherapy and PD-1 blockade at the same time.

Also known as: irradiation

Treatment arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients 18-75 years old with the right to make medical decisions
• Signed informed consent form
• ECOG score of 0-2
• Clear pathological diagnosis of the primary site
• Multiple distant metastases
• Stable assessment of brain metastases after treatment can be enrolled (more than 6 weeks)
• Bone metastases combined with soft tissue mass formation can be enrolled
• imaging with ≥ 2 clearly assessable lesions (bone metastases alone without soft tissue mass formation, brain metastases not as target lesions)
• expected survival ≥ 6 months
• Progression after ≥ 1 prior line of therapy regimen with no standard treatment regimen or intolerable toxicities, including all three of the following:
• Patients must have failed to respond to at least one prior standard of care regimen
• The patient must not have a conventional treatment option that is clinically proven to provide long-term control of the disease and the patient refuses other conventional treatment options
• The patient is intolerant to the toxic side effects of the standard treatment regimen
• No prior immunotherapy history
• Time to last systemic therapy (including monoclonal antibodies) ≥ 4 weeks

You may not qualify if:

• Uncontrolled brain metastases (stabilization time \<6 weeks)
• Bone metastases alone without clear soft tissue mass formation
• Bone marrow infiltration
• Presence of clinical factors (e.g., bleeding, active infection, or psychiatric factors) that the investigator determines may interfere with the completion of the study process
• Inability to administer radiotherapy due to organ-threatening or other factors as assessed by the investigator
• Patients requiring long-term maintenance steroid therapy (including oral, intravenous use); topical use or inhalation may be included in the study
• history of active tuberculosis or non-infectious pneumonia or any clinical evidence
• Active viral hepatitis with HBV DNA \> 500 IU/ml
• Immunodeficiency syndrome
• comorbid serious medical disorders with concomitant diseases or conditions affecting the normal enrollment of the patient or safety during the study
• previous immunotherapy for other tumors
• History of other malignancies within 5 years (except cured basal cell carcinoma of the skin);
• Pregnant or lactating women;
• Unable or unwilling to sign the informed consent form.

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Interventions

Radiation

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

• Jiayi Chen, MD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yujie Wang, MD

CONTACT

8602164370045; wyj12054@rjh.com.cn

Yunsheng Gao, MD

CONTACT

gys11856@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Radiation Oncology

Study Record Dates

• First Submitted: July 28, 2021
• First Posted: October 28, 2021
• Study Start: March 21, 2021
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2024
• Last Updated: October 28, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)