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Trial Title:
Thalidomide Prevention or Treatment of Camrelizumab-induced Reactive Cutaneous Capillary Endothelial Proliferation (RCCEP)
NCT ID:
NCT06231680
Condition:
Lung Cancer, Nonsmall Cell
Esophageal Carcinoma
Conditions: Official terms:
Esophageal Neoplasms
Carcinoma, Non-Small-Cell Lung
Thalidomide
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Camrelizumab
Description:
Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or
unacceptable toxicity
Arm group label:
Prevention Cohort 1 Group A
Arm group label:
Prevention Cohort 1 Group B
Other name:
SHR-1210
Intervention type:
Drug
Intervention name:
Thalidomide 50mg
Description:
Thalidomide 50mg，po qd；
Arm group label:
Prevention Cohort 1 Group A
Other name:
Thalidomide
Intervention type:
Drug
Intervention name:
Thalidomide 100mg
Description:
Thalidomide 100mg，po qd；
Arm group label:
Prevention Cohort 1 Group B
Arm group label:
Treatment Cohort 2 Group A
Other name:
Thalidomide
Intervention type:
Drug
Intervention name:
Thalidomide 200mg
Description:
Thalidomide 200mg，po qd；
Arm group label:
Treatment Cohort 2 Group B
Other name:
Thalidomide
Intervention type:
Drug
Intervention name:
Chemotherapy
Description:
Platinum-based chemotherapy:
1. Esophageal squamous cell carcinoma: cisplatin/carboplatin/nedaplatin/lobaplatin+
paclitaxel/albumin-bound paclitaxel/fluorouracil on Day 1 of each 21-day cycle for
4-6 cycles;
2. Non-small cell lung cancer (non-squamous cell carcinoma): pemetrexed plus
carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles，pemetrexed every
three weeks (Q3W) maintenance for the remainder of the study or until documented PD;
3. Non-small cell lung cancer (squamous cell carcinoma) : paclitaxel/albumin-bound
paclitaxel + carboplatin/cisplatin on Day 1 of each 21-day cycle for 4-6 cycles.
Arm group label:
Prevention Cohort 1 Group A
Arm group label:
Prevention Cohort 1 Group B
Other name:
Platinum-based chemotherapy
Summary:
To explore the dose and safety of thalidomide for the prevention and treatment of
camrelizumab-induced reactive cutaneous capillary endothelial proliferation (RCCEP)
Detailed description:
1. To increase the evidence of thalidomide for the prevention of RCCEP, the
investigators will explore the dose of thalidomide for the prevention of RCCEP in
participants with esophageal squamous cell carcinoma and non-small cell lung cancer
who were scheduled to receive camrelizumab combined with platinum-based
chemotherapy;
2. To increase the evidence of thalidomide for the treatment of RCCEP, the
investigators will explore the dose of thalidomide for the treatment of ≥G2 RCCEP in
participants with esophageal squamous cell carcinoma and non-small cell lung cancer
with camrelizumab
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Prevention cohort 1:
1. Histopathology or cytology confirmed advanced non-small cell lung cancer or
esophageal squamous cell carcinoma; no previous systemic therapy (patients who
had progressed ≥6 months after [neo] adjuvant therapy were eligible).
2. A treatment regimen of Camrelizumab combined with platinum-containing
chemotherapy is planned.
3. ECOG: 0-1;
4. Age ≥18 years old;
5. Have a life expectancy of at least 12 weeks;
6. No prior therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (including
any other antibody or drug specifically targeting T-cell co-stimulation or
checkpoint pathways).
7. Can swallow pills normally;
8. Adequate organ and bone marrow function：Standard of blood routine examination
(without transfusion within 14 days) : Hemoglobin (HB) ≥80 g/L; Neutrophil
absolute value (ANC) ≥1.5×10^9/L; Platelet (PLT) ≥90×10^9/L;Biochemical
examination should meet the following criteria: Total bilirubin (TBIL) ≤1.5
times the upper limit of normal value (ULN); Alanine aminotransferase (ALT),
aspartate aminotransferase (AST) ≤3×ULN; Serum creatinine (Cr) ≤1.5 ULN;
9. Female Subjects of childbearing potential must have a negative serum pregnancy
test within 72 hours before the first dose and must be willing to use very
efficient barrier methods of contraception for the course of the study through
2 months after the last dose of study treatment. Male Subjects with a female
partner(s) of child-bearing potential must be willing to use very efficient
barrier methods of contraception for the course of the study through 2 months
after the last dose of study treatment;
10. Subjects has voluntarily agreed to participate by giving written informed
consent/assent for the trial.
- Treatment cohort 2:
1. Histopathology or cytology confirmed advanced lung cancer or esophageal
carcinoma;
2. Subjects had≥G2 grade RCCEP for the first time after treatment with a
Camrelizumab based regimen;
3. ECOG: 0-2;
4. Age ≥18 years old;
5. Have a life expectancy of at least 12 weeks;
6. Can swallow pills normally;
7. No ongoing grade 3 or higher adverse events except for RCCEP (according to
CTCAE version 5.0).
8. Female Subjects of childbearing potential must have a negative serum pregnancy
test within 72 hours before the first dose and must be willing to use very
efficient barrier methods of contraception for the course of the study through
2 months after the last dose of study treatment. Male Subjects with a female
partner(s) of child-bearing potential must be willing to use very efficient
barrier methods of contraception for the course of the study through 2 months
after the last dose of study treatment;
9. Subjects have voluntarily agreed to participate by giving written informed
consent/assent for the trial.
Exclusion Criteria:
- Prevention cohort 1:
1. Known allergy to the investigational drug or excipient, history of severe
hypersensitivity reactions to other monoclonal antibodies.
2. Subjects with a condition requiring systemic treatment with other
immunosuppressive medications within 14 days of first administration of study
treatment.
3. Subjects had administration of a live, attenuated vaccine within 4 weeks of the
first dose of study treatment or anticipation that such a live attenuated
vaccine will be required during the study.
4. Advanced patients who have symptoms, have spread to the internal organs, and
are at risk of developing life-threatening complications in the short term;
5. Subjects with a history of interstitial lung disease, or other disease may
interfere with the detection or treatment of suspected drug-related lung
toxicity.
6. Subjects with active, known or suspected autoimmune disease. Subjects in
conditions not expected to recur in the absence of an external trigger, or not
requiring systemic treatment are permitted to enroll.
7. HIV infection; Combined hepatitis B and hepatitis C co-infection
8. Subjects with active CNS metastases are excluded.
9. Subjects with clinically significant cardiovascular and cerebrovascular
diseases.
10. Coagulation abnormalities, with bleeding tendency or are receiving thrombolytic
or anticoagulant therapy;
11. Disposition evidence of hemoptysis in 2 months (bright red blood, 1/2
teaspoon).
12. History of hemorrhage within 3 months prior to the start of study treatment or
clear tendency of hemorrhage
13. Thrombosis or thromboembolic event within 6 months prior to the start of study
treatment;
14. Active infection (CTCAE> Grade 2)
15. Subjects had or plan to have allogeneic bone marrow transplantation or solid
organ transplant.
16. Subjects are currently participating and receiving study therapy or had
participated in a study of an investigational agent and received study therapy
or used an investigational device within 4 weeks or 5 half-value period life of
the agent, before the first dose of trial treatment.
17. Subjects have known psychiatric or substance abuse disorder
18. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
subject's participation for the full duration of the study, or is not in the
best interest of the subject to participate, in the opinion of the treating
Investigator.
- Treatment cohort 2:
1. Known allergy to the investigational drug or excipient
2. Advanced patients who have symptoms, have spread to the internal organs, and
are at risk of developing life-threatening complications in the short term;
3. Subjects with a history of interstitial lung disease, or other disease may
interfere with the detection or treatment of suspected drug-related lung
toxicity.
4. HIV infection; Combined hepatitis B and hepatitis C co-infection
5. Active infection (CTCAE> Grade 2)
6. Subjects have known psychiatric or substance abuse disorder
7. Has a history or current evidence of any condition, therapy, or laboratory
abnormality that might confound the results of the study, interfere with the
subject's participation for the full duration of the study, or is not in the
best interest of the subject to participate, in the opinion of the treating
Investigator
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ying Liu
Address:
City:
Zhengzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Ying Liu, MD
Phone:
+8613783604602
Email:
yaya7207@126.com
Investigator:
Last name:
Ying Liu, MD
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Yu Yao, MD
Investigator:
Last name:
Yu Yao, MD
Email:
Principal Investigator
Start date:
January 19, 2024
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Henan Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Source:
Henan Cancer Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06231680
