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Status unknownNCT05097781Updated Oct 28, 2021

Local Radiotherapy in Combination With Immunotherapy in Advanced Solid Tumors Patients

A Phase 2 interventional study of PD-1 blocking antibody in Solid Tumor, sponsored by Ruijin Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-10-28.

Sponsored by Ruijin Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Mar 2021, registered Jul 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
55
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

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Conditions studied

  • Solid Tumor

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 55 is close to the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Ruijin Hospital is the lead sponsor of 635 studies on the registry; 359 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adult patients 18-75 years old with the right to make medical decisions
  2. Signed informed consent form
  3. ECOG score of 0-2
  4. Clear pathological diagnosis of the primary site
  5. Multiple distant metastases
  6. Stable assessment of brain metastases after treatment can be enrolled (more than 6 weeks)
  7. Bone metastases combined with soft tissue mass formation can be enrolled
  8. imaging with ≥ 2 clearly assessable lesions (bone metastases alone without soft tissue mass formation, brain metastases not as target lesions)
  9. expected survival ≥ 6 months
  10. Progression after ≥ 1 prior line of therapy regimen with no standard treatment regimen or intolerable toxicities, including all three of the following:

    1. Patients must have failed to respond to at least one prior standard of care regimen
    2. 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
    3. The patient is intolerant to the toxic side effects of the standard treatment regimen
  11. No prior immunotherapy history
  12. Time to last systemic therapy (including monoclonal antibodies) ≥ 4 weeks
  13. Previous radiotherapy to non-target sites with other evaluable lesions can be enrolled
  14. Laboratory examination indexes meet the following requirements: WBC ≥ 3×109/L, ANC ≥ 2.0×109/L, PLT ≥ 80×109/L, Hb ≥ 80g/L (according to the normal standards of the central laboratory department); liver function: total bilirubin, ALT and AST are ≤ 1.5xUNL (upper limit of normal value); AST (SGOT)/ALT (SGPT) ≤ 2.5xUNL (upper limit of normal value) ALT (SGPT) ≤ 2.5 x IULN (upper limit of normal value); renal function: Cr≦1.5xUNL (upper limit of normal value), and creatinine clearance rate≧60ml/min; thyroid function T3, T4 within normal range (hypothyroidism can be supplemented with oral thyroxine); cardiac function: cardiac protein three and pro-BNP within normal range, no previous Adrenal function: normal cortisol secretion function or correctable by endocrine assessment
  15. HBV infected patients with HBV-DNA copy number less than 500 IU/ml
  16. No history of other malignancies within 5 years (except skin basal cell carcinoma)

Exclusion criteria

Exclusion Criteria:

  1. Uncontrolled brain metastases (stabilization time \<6 weeks)
  2. Bone metastases alone without clear soft tissue mass formation
  3. Bone marrow infiltration
  4. 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
  5. Inability to administer radiotherapy due to organ-threatening or other factors as assessed by the investigator
  6. Patients requiring long-term maintenance steroid therapy (including oral, intravenous use); topical use or inhalation may be included in the study
  7. Prior autoimmune disease or active disease [e.g., including but not limited to inflammatory bowel disease [IBD], rheumatoid arthritis, autoimmune hepatitis, systemic sclerosis (scleroderma and its variants), systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathy (e.g., Guillain-Barre syndrome)], vitiligo and correctable endocrine deficiencies such as thyroid hypofunction, physiological cortisol hypersecretion may be included in the study and are not considered as exclusion criteria.
  8. history of active tuberculosis or non-infectious pneumonia or any clinical evidence
  9. Active viral hepatitis with HBV DNA > 500 IU/ml
  10. Immunodeficiency syndrome
  11. comorbid serious medical disorders with concomitant diseases or conditions affecting the normal enrollment of the patient or safety during the study
  12. previous immunotherapy for other tumors
  13. History of other malignancies within 5 years (except cured basal cell carcinoma of the skin);
  14. Pregnant or lactating women;
  15. Unable or unwilling to sign the informed consent form.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
55 participants (estimated)

Study arms

  • Experimental
    Treatment arm

    Local irradiation + immunotherapy

    Drug: PD-1 blocking antibody

Interventions

  • DrugPD-1 blocking antibody

    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

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 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

  2. non-irradiated lesion control rate(NRCR)

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

    Time frame: 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

  1. Progression free survival

    The time from enrollment to disease progression or death from any cause

    Time frame: 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

  2. Overall survival

    The time from enrollment to death from any cause

    Time frame: 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

  3. Rate of side effects

    ≥ grade 3 adverse effects

    Time frame: 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

07

Study locations

1 of 1 sites recruiting
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
    Shanghai, Shanghai 200025, China
    • Jiayi Chen, MD · Contact · cjy11756@rjh.com.cn · +86-021-64370045
    • Jiayi Chen, MD · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05097781
Lead sponsor
Ruijin Hospital
Responsible party
Jiayi Chen (Chief of Department of Radiation Oncology, Ruijin Hospital) — Principal investigator
First posted
Oct 28, 2021
Start date
Mar 21, 2021
Primary completion
Jun 2023 (estimated)
Completion
Sep 2024 (estimated)
Last update
Oct 28, 2021

Study contacts

Yujie Wang, MD
Contact
wyj12054@rjh.com.cn
8602164370045 ext. 602400
Yunsheng Gao, MD
Contact
gys11856@rjh.com.cn
Jiayi Chen, MD
principal investigator · Ruijin Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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