Search / Trial NCT06612632

Immunotherapy Rechallenge in Patients with Solid Tumors in Clinical Trials

Launched by CANCER INSTITUTE AND HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES · Sep 23, 2024

Trial Information

Current as of October 08, 2024

Recruiting

Keywords

Immunotherapy Rechallenge Clinical Trail Solid Tumor

Description

This study plans to include approximately 60-100 patients with advanced solid tumors who have progressed on clinical trial drugs, using an open-label, single-arm, multi-cohort umbrella design. In the first phase, patients who have progressed during treatment with novel tumor immunotherapy drugs will initially be targeted, combining or sequencing with PD-1 monoclonal antibody therapy. The selection criteria for frontline clinical trials are as follows: priority will be given to phase I clinical trials of novel immunotherapeutics as monotherapy, such as tumor vaccines, NK cell therapy, and ne...

Gender

ALL

Eligibility criteria

  • 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

About Cancer Institute And Hospital, Chinese Academy Of Medical Sciences

The Cancer Institute and Hospital of the Chinese Academy of Medical Sciences is a leading research and treatment center dedicated to advancing cancer care through innovative clinical trials and comprehensive patient services. As a prominent institution in oncology, it focuses on integrating cutting-edge research with clinical practice, fostering collaborations that enhance the understanding and treatment of various cancer types. The institute is committed to improving patient outcomes by exploring novel therapies, optimizing treatment protocols, and contributing to the global fight against cancer through rigorous scientific investigation and evidence-based practices.

Locations

Beijing, , China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0