Immunotherapy rechallenge for patients with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enroll approximately 60-100 patients with advanced solid tumors who have experienced disease progression on previous clinical trial drugs. It employs an open-label, single-arm, multi-cohort design, initially focusing on patients who have progressed during treatment with novel tumor immunotherapy drugs, combining or sequencing these with PD-1 monoclonal antibody therapy. The study will prioritize patients from phase I clinical trials of new immunotherapeutics, such as tumor vaccines and immune checkpoint inhibitors, and will expand to include those who have progressed on other treatments. The design includes combination therapy cohorts, sequential therapy cohorts, and real-world cohorts to assess the efficacy of these approaches.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Recurrent or metastatic solid tumors confirmed by histopathology that cannot be treated with curative local therapy
2. Prior systemic anti-tumor treatment requirements: Previous first-line treatment involved a clinical trial of a new drug, with disease progression, and deemed by the investigator to no longer benefit from it
3. Suggested first dose administered within 12 weeks after the last treatment.
4. According to the RECIST 1.1 criteria, there should be at least one measurable lesion or more
5. ECOG PS 0-2 points
6. expected survival ≥ 3 months
7. as assessed by the investigator, major organ functions are good enough and can tolerate the experimental treatment regimen used in this study
8. subjects can understand and comply with the study procedures, sign the informed consent form, and voluntarily participate in this study
9. patients included in the real-world cohort who do not meet the aforementioned inclusion criteria or refuse to participate in the aforementioned interventional experimental treatment

Exclusion Criteria:

1. Previous exposure to immunotherapy (standard treatment or clinical trials) resulted in severe immune-related adverse events, as assessed by the investigator, making the re-administration of immunotherapy inappropriate.
2. Previous adverse reactions to advanced solid tumors have persisted, and the investigator anticipates these might impact the safety evaluation of the investigational drug
3. Previously experienced hyperprogression during immune therapy (conventional treatment or clinical trials), and the Other conditions deemed unsuitable for participation in this study by the investigator believes that no further benefit can be gained from this study. Criteria include: (1) Tumor progression time less than two months during immunotherapy
4. (2) Tumor burden increased by over 50% compared to baseline
5. (3) Tumor growth rate post-immunotherapy exceeds twice the previous rate
6. Central nervous system metastases or leptomeningeal metastases with clinical symptoms
7. During the screening period, subjects are determined by the investigator to have severe or uncontrolled underlying diseases (such as hypertension, diabetes, cardiovascular diseases, pulmonary diseases, autoimmune diseases, etc.)
8. Received other anti-tumor therapy between the last front-line therapy and the first dose of the study drug
9. Other conditions deemed unsuitable for participation in this study by the investigator

Where it's running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  Beijing, China Recruiting

Study contacts

• Principal investigator: Ning Li — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Dawei Wu, Dr.
• Email: wumingshi-117@163.com
• Phone: (+86)-010-87788165

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Cadonilimab and Lenvatinib in advanced kidney cancer

  This study tests whether Cadonilimab plus Lenvatinib can help adults with unresectable, advanced renal cell carcinoma, especially clear cell type, after prior treatments.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Panjiayuan Nanli · NCT07909265

• Neoadjuvant therapy with nimotuzumab, toripalimab, nab-paclitaxel, and cisplatin for locally advanced head and neck cancer

  This study tests a pre-surgery treatment combining targeted therapy, immunotherapy, and chemotherapy to see if it helps patients with locally advanced, resectable head and neck squamous cell carcinoma.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Hebei, Hebei · NCT07906587

• Toripalimab Plus Cetuximab and Irinotecan for second-line right-sided colon cancer

  This phase II study tests whether a combo of toripalimab, cetuximab, and irinotecan helps adults with second-line, right‑sided, RAS/BRAF wild-type advanced colon cancer.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07896681

• Primary tumor removal with targeted lymph node removal plus radiation for biliary tract cancer with lymph node spread

  This phase II study tests whether removing the main tumor and select nearby lymph nodes, followed by postoperative radiation, helps patients with biliary tract cancer and lymph node metastases.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07893392

• Three-dimensional lattice radiotherapy with PD-1/PD-L1 inhibitors for advanced solid tumors

  This study tests whether adding lattice radiotherapy to PD-1/PD-L1 inhibitors is safe and helps people with advanced solid tumors that have grown or spread.

  Recruiting Phase 2 Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Shenzhen, Guangdong · NCT07865793

• Radiotherapy target-volume choices in locally advanced esophageal cancer during immunotherapy

  This observational study looks at how doctors outline the radiation area for locally advanced esophageal squamous cell cancer patients treated with radiotherapy and immunotherapy to see which approaches correlate with better outcomes.

  Recruiting Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Beijing, Beijing Municipality · NCT07858630

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.