Status:
UNKNOWN
The Safety and Tolerability of PD-L1 Monoclonal Antibody Plus Lenalidomide in The Treatment of Colorectal Cancer
Lead Sponsor:
LiNing
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study proposed by increasing dosage and expand the "3 + 3" queue, main component is divided into two phases, phase 1 for dose escalation, according to preliminary data recommended doses starting ...
Detailed Description
1. Phase 1 was the dose increasing phase, which was divided into three queues (A, B and C). Each team was included in the group of three people.Cohort B: pd-l1 monoclonal antibody 900mg q3w+ lenalidom...
Eligibility Criteria
Inclusion
- Aigned informed consent
- Only patients aged 18-75 years were enrolled
- Patients with advanced colorectal cancer diagnosed by pathology and imaging.Note: the presence of distant metastases should be confirmed by a CT or MR scan.Bone scan should be performed if bone metastases are suspected.Local radiotherapy for pain relief is permitted for bone metastases.
- Measurable lesions based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 must be present.Local radiotherapy of target lesions is not allowed.
- pMMR/MSS advanced colorectal cancer patients with disease progression or intolerance to third-line treatment after failure of current standard third-line treatment
- ECOG 1 minute or less
- Tumor specimens that can be used to detect the status of pd-l1, MSI, b-raf and k-ras can be provided.This test requires the patient to provide paraffin embedded biopsy specimens or white slices.
- White blood cells ≥ 4×109/L, platelets ≥ 100×109/L without transfusion, neutrophil absolute value (ANC) ≥ 1.5×109/L without treatment with granulocyte stimulating factor, and hemoglobin ≥ 90 g/L.
- Bilirubin ≤ 1.5 times of the upper limit of normal value, and cereal grass and cereal propyl transaminase ≤ 2.5 times of the upper limit of normal value.
- Serum creatinine ≤ 1.5 times the upper limit of normal value, or GFR\>45 ml/min
- Serum albumin ≥ 25 g/L (2.5g /dL)
- INR or APTT ≤ 1.5 times ULN
- Hepatitis B/C surface antigen positive patients need to be tested for Hepatitis B /C virus DNA quantitative test, only \< the upper limit of the normal detection value can be included in the group, and long-term use of anti-hb/hc drugs
- Drug elution time: 28 days or 5 half-lives from the last drug application.
Exclusion
- Allergy to any experimental drug or its excipients, or history of severe allergy, or contraindication to the experimental drug
- Having a history of autoimmune disease or being active
- Previous allogeneic bone marrow transplantation or organ transplantation
- Congenital pulmonary fibrosis, drug-induced pneumonia, organized pneumonia, or ct-confirmed active pneumonia
- HIV positive
- Active Hepatitis B /C(Hepatitis B /C viruses have higher quantification than normal)
- Active stage tuberculosis
- Uncontrolled cancer pain
- A live attenuated vaccine was injected within 4 weeks before the study began, or a live attenuated vaccine is expected to be injected during the trial or within 5 months after the end of the trial
- Previous use of immunotherapy, including CTLA4, anti-PD-1, or anti-PD-L1 monoclonal antibody
- CT indicates lung active inflammation
- Systemic administration of glucocorticoids or immunosuppressants within 2 weeks prior to the trial.Inhaled corticosteroids and halocorticoids are allowed
- Use of hormones is contraindicated
- Serious cardiovascular disease, myocardial infection, arteriovenous thrombosis or cerebrovascular accident, arrhythmia, unstable angina pectoris within 3 months before the trial
- Uncontrollable increase in blood pressure or blood sugar
- History of other malignancies 5 years ago, except for carcinoma in situ of the cervix, non-melanoma skin cancer or stage I uterine cancer
- Peripheral neuropathy of grade 2 ≥ NCI CTCAE
- Serum albumin less than 2.5g /dL
- Uncontrolled or symptomatic hypercalcemia
- Infection requiring antibiotics within 14 days prior to trial
- Chronic enteritis
- Clinically significant active gastrointestinal bleeding
- Non-diagnostic surgery within 4 weeks before the trial
- Any other disease for which there is evidence that the use of the experimental drug needs to be restricted
- Participate in other trials within 30 days prior to the trial or plan to participate in other trials during the trial
- Receive other experimental drugs within 28 days before the start of the trial
- Women who are pregnant or lactating, or who plan to become pregnant within 5 months after the end of treatment.Women of childbearing age should undergo a blood pregnancy test 7 days before the start of the trial
- Use of PD-L1 monoclonal antibody or lenalidomide contraindications
- MSI-H/dMMR in patients with advanced colorectal cancer
Key Trial Info
Start Date :
May 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT04326296
Start Date
May 30 2020
End Date
March 1 2023
Last Update
May 15 2020
Active Locations (1)
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1
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008