Last updated: March 27, 2024
Sponsor: Henan Cancer Hospital
Overall Status: Active - Recruiting
Phase
2
Condition
Carcinoma
Esophageal Cancer
Esophageal Disorders
Treatment
Thalidomide 200mg
Thalidomide 50mg
Chemotherapy
Clinical Study ID
NCT06231680
MA-RCCEP-II-001
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Prevention cohort 1:
- Histopathology or cytology confirmed advanced non-small cell lung cancer oresophageal squamous cell carcinoma; no previous systemic therapy (patients whohad progressed ≥6 months after [neo] adjuvant therapy were eligible).
- A treatment regimen of Camrelizumab combined with platinum-containingchemotherapy is planned.
- ECOG: 0-1;
- Age ≥18 years old;
- Have a life expectancy of at least 12 weeks;
- No prior therapy with anti-PD-1, anti-PD-L1, or anti-CTLA-4 antibody (includingany other antibody or drug specifically targeting T-cell co-stimulation orcheckpoint pathways).
- Can swallow pills normally;
- Adequate organ and bone marrow function:Standard of blood routine examination (without transfusion within 14 days) : Hemoglobin (HB) ≥80 g/L; Neutrophilabsolute value (ANC) ≥1.5×10^9/L; Platelet (PLT) ≥90×10^9/L;Biochemicalexamination should meet the following criteria: Total bilirubin (TBIL) ≤1.5 timesthe upper limit of normal value (ULN); Alanine aminotransferase (ALT), aspartateaminotransferase (AST) ≤3×ULN; Serum creatinine (Cr) ≤1.5 ULN;
- Female Subjects of childbearing potential must have a negative serum pregnancytest within 72 hours before the first dose and must be willing to use veryefficient barrier methods of contraception for the course of the study through 2months after the last dose of study treatment. Male Subjects with a femalepartner(s) of child-bearing potential must be willing to use very efficientbarrier methods of contraception for the course of the study through 2 monthsafter the last dose of study treatment;
- Subjects has voluntarily agreed to participate by giving written informedconsent/assent for the trial.
- Treatment cohort 2:
- Histopathology or cytology confirmed advanced lung cancer or esophagealcarcinoma;
- Subjects had≥G2 grade RCCEP for the first time after treatment with aCamrelizumab based regimen;
- ECOG: 0-2;
- Age ≥18 years old;
- Have a life expectancy of at least 12 weeks;
- Can swallow pills normally;
- No ongoing grade 3 or higher adverse events except for RCCEP (according to CTCAEversion 5.0).
- Female Subjects of childbearing potential must have a negative serum pregnancytest within 72 hours before the first dose and must be willing to use veryefficient barrier methods of contraception for the course of the study through 2months after the last dose of study treatment. Male Subjects with a femalepartner(s) of child-bearing potential must be willing to use very efficientbarrier methods of contraception for the course of the study through 2 monthsafter the last dose of study treatment;
- Subjects have voluntarily agreed to participate by giving written informedconsent/assent for the trial.
Exclusion
Exclusion Criteria:
- Prevention cohort 1:
- Known allergy to the investigational drug or excipient, history of severehypersensitivity reactions to other monoclonal antibodies.
- Subjects with a condition requiring systemic treatment with otherimmunosuppressive medications within 14 days of first administration of studytreatment.
- Subjects had administration of a live, attenuated vaccine within 4 weeks of thefirst dose of study treatment or anticipation that such a live attenuated vaccinewill be required during the study.
- Advanced patients who have symptoms, have spread to the internal organs, and areat risk of developing life-threatening complications in the short term;
- Subjects with a history of interstitial lung disease, or other disease mayinterfere with the detection or treatment of suspected drug-related lungtoxicity.
- Subjects with active, known or suspected autoimmune disease. Subjects inconditions not expected to recur in the absence of an external trigger, or notrequiring systemic treatment are permitted to enroll.
- HIV infection; Combined hepatitis B and hepatitis C co-infection
- Subjects with active CNS metastases are excluded.
- Subjects with clinically significant cardiovascular and cerebrovascular diseases.
- Coagulation abnormalities, with bleeding tendency or are receiving thrombolyticor anticoagulant therapy;
- Disposition evidence of hemoptysis in 2 months (bright red blood, 1/2 teaspoon).
- History of hemorrhage within 3 months prior to the start of study treatment orclear tendency of hemorrhage
- Thrombosis or thromboembolic event within 6 months prior to the start of studytreatment;
- Active infection (CTCAE> Grade 2)
- Subjects had or plan to have allogeneic bone marrow transplantation or solidorgan transplant.
- Subjects are currently participating and receiving study therapy or hadparticipated in a study of an investigational agent and received study therapy orused an investigational device within 4 weeks or 5 half-value period life of theagent, before the first dose of trial treatment.
- Subjects have known psychiatric or substance abuse disorder
- Has a history or current evidence of any condition, therapy, or laboratoryabnormality that might confound the results of the study, interfere with thesubject's participation for the full duration of the study, or is not in the bestinterest of the subject to participate, in the opinion of the treatingInvestigator.
- Treatment cohort 2:
- Known allergy to the investigational drug or excipient
- Advanced patients who have symptoms, have spread to the internal organs, and areat risk of developing life-threatening complications in the short term;
- Subjects with a history of interstitial lung disease, or other disease mayinterfere with the detection or treatment of suspected drug-related lungtoxicity.
- HIV infection; Combined hepatitis B and hepatitis C co-infection
- Active infection (CTCAE> Grade 2)
- Subjects have known psychiatric or substance abuse disorder
- Has a history or current evidence of any condition, therapy, or laboratoryabnormality that might confound the results of the study, interfere with thesubject's participation for the full duration of the study, or is not in the bestinterest of the subject to participate, in the opinion of the treatingInvestigator
Study Design
Total Participants: 132
Treatment Group(s): 5
Primary Treatment: Thalidomide 200mg
Phase: 2
Study Start date:
January 19, 2024
Estimated Completion Date:
September 30, 2025
Study Description
Connect with a study center
Ying Liu
Zhengzhou, Henan
ChinaActive - Recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi
ChinaSite Not Available
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