Search / Trial NCT06231680

Thalidomide Prevention or Treatment of Camrelizumab-induced Reactive Cutaneous Capillary Endothelial Proliferation (RCCEP)

Launched by HENAN CANCER HOSPITAL · Jan 26, 2024

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Trial Information

Current as of December 21, 2024

Recruiting

Keywords

ClinConnect Summary

This clinical trial is investigating how well a medication called thalidomide can help prevent or treat a skin condition known as Reactive Cutaneous Capillary Endothelial Proliferation (RCCEP), which can occur in patients receiving camrelizumab for lung cancer or esophageal carcinoma. The trial aims to assess the safety and appropriate dosage of thalidomide for patients who are starting treatment with camrelizumab or who have already developed RCCEP after their treatment.

To participate in this trial, patients must be at least 18 years old and have a confirmed diagnosis of advanced lung cancer or esophageal cancer. They should not have received certain prior treatments and must be in generally good health, with a life expectancy of at least 12 weeks. Participants will take thalidomide in pill form and will be monitored closely throughout the study to ensure their safety. It’s also important for participants to use effective contraception during the study if they are of childbearing potential. This trial is currently recruiting participants, and those who are interested should discuss it with their healthcare provider to see if they qualify.

Gender

ALL

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

Trial Officials

Ying Liu, MD

Principal Investigator

Henan Cancer Hospital

Yu Yao, MD

Principal Investigator

First Affiliated Hospital Xi'an Jiaotong University

About Henan Cancer Hospital

Henan Cancer Hospital, a leading institution in oncology care and research, is dedicated to advancing cancer treatment through innovative clinical trials. With a commitment to improving patient outcomes, the hospital combines cutting-edge medical expertise with state-of-the-art facilities to conduct research that addresses critical gaps in cancer therapy. As a prominent sponsor of clinical trials, Henan Cancer Hospital focuses on developing novel therapeutic approaches and enhancing existing treatment protocols, fostering a collaborative environment that engages both patients and healthcare professionals in the pursuit of improved cancer care.

Locations

Xi'an, Shaanxi, China

Zhengzhou, Henan, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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