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

NCT06231680 | Unknown Phase 2

• 1 other identifier: MA-RCCEP-II-001
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 2

Brief Summary

To explore the dose and safety of thalidomide for the prevention and treatment of camrelizumab-induced reactive cutaneous capillary endothelial proliferation (RCCEP)

Conditions

Lung Cancer, Nonsmall Cell; Esophageal Carcinoma

Outcome Measures

Primary Outcomes (2)

• Incidence rate of RCCEP

  Incidence rate of RCCEP

  2 years

• RCCEP response rate at 3 weeks

  RCCEP response rate at 3 weeks

  3 weeks

Secondary Outcomes (6)

• Incidence rate of ≥G3 grade RCCEP

  2 years

• Median time to RCCEP

  2 years

• Incidence rate of RCCEP at 6 weeks

  6 weeks

• Incidence rate of RCCEP at 9 weeks

  9 weeks

• Median time to response of RCCEP

  2 years

Study Arms (4)

Prevention Cohort 1 Group A

EXPERIMENTAL

Camrelizumab + chemotherapy+Thalidomide(50mg)

Drug: Camrelizumab; Drug: Thalidomide 50mg; Drug: Chemotherapy

Prevention Cohort 1 Group B

EXPERIMENTAL

Camrelizumab + chemotherapy+Thalidomide(100mg)

Drug: Camrelizumab; Drug: Thalidomide 100mg; Drug: Chemotherapy

Treatment Cohort 2 Group A

EXPERIMENTAL

Thalidomide(100mg)

Drug: Thalidomide 100mg

Treatment Cohort 2 Group B

EXPERIMENTAL

Thalidomide(200mg)

Drug: Thalidomide 200mg

Interventions

Camrelizumab DRUG

Camrelizumab 200mg intravenous (IV) on Day 1 of each 21-day cycle，until progression or unacceptable toxicity

Also known as: SHR-1210

Prevention Cohort 1 Group A; Prevention Cohort 1 Group B

Thalidomide 50mg DRUG

Thalidomide 50mg，po qd；

Also known as: Thalidomide

Prevention Cohort 1 Group A

Thalidomide 100mg DRUG

Thalidomide 100mg，po qd；

Also known as: Thalidomide

Prevention Cohort 1 Group B; Treatment Cohort 2 Group A

Thalidomide 200mg DRUG

Thalidomide 200mg，po qd；

Also known as: Thalidomide

Treatment Cohort 2 Group B

Chemotherapy DRUG

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.

Also known as: Platinum-based chemotherapy

Prevention Cohort 1 Group A; Prevention Cohort 1 Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Prevention cohort 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).
• A treatment regimen of Camrelizumab combined with platinum-containing chemotherapy 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 (including any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint 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; 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;
• 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;
• Subjects has voluntarily agreed to participate by giving written informed consent/assent for the trial.
• Treatment cohort 2:
• Histopathology or cytology confirmed advanced lung cancer or esophageal carcinoma;
• Subjects had≥G2 grade RCCEP for the first time after treatment with a Camrelizumab based regimen;
• ECOG: 0-2;

You may not qualify if:

• Prevention cohort 1:
• Known allergy to the investigational drug or excipient, history of severe hypersensitivity reactions to other monoclonal antibodies.
• Subjects with a condition requiring systemic treatment with other immunosuppressive medications within 14 days of first administration of study treatment.
• 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.
• Advanced patients who have symptoms, have spread to the internal organs, and are at risk of developing life-threatening complications in the short term;
• Subjects with a history of interstitial lung disease, or other disease may interfere with the detection or treatment of suspected drug-related lung toxicity.
• 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.
• 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 thrombolytic or 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 or clear tendency of hemorrhage
• Thrombosis or thromboembolic event within 6 months prior to the start of study treatment;
• Active infection (CTCAE\> Grade 2)

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (2)

Ying Liu

Zhengzhou, Henan, China

RECRUITING

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Esophageal Neoplasms

Interventions

camrelizumab; Thalidomide; Drug Therapy; Platinum Compounds

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Inorganic Chemicals

Study Officials

• Ying Liu, MD

  Henan Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Yu Yao, MD

  First Affiliated Hospital Xi'an Jiaotong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Liu, MD

CONTACT

+86 137 8360 4602; yaya7207@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Chief Physician

Study Record Dates

• First Submitted: November 7, 2023
• First Posted: January 30, 2024
• Study Start: January 19, 2024
• Primary Completion: June 30, 2024
• Study Completion: September 30, 2025
• Last Updated: March 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)