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Lung Cancer, Nonsmall CellPhase 2NCT06231680

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

A Phase 2 study testing Camrelizumab, Thalidomide 50mg and Thalidomide 100mg in people with Lung Cancer, Nonsmall Cell and Esophageal Carcinoma, run by Henan Cancer Hospital at 2 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Camrelizumab, Thalidomide 50mg and Thalidomide 100mg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
132 participants
Where
2 sitesChina
Study dates
19 Jan 2024to 30 Sep 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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;
  • 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 CTCAE version 5.0).
  • 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 have voluntarily agreed to participate by giving written informed consent/assent for the trial.

Who cannot join

  • 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.
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  • 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)
  • Subjects had or plan to have allogeneic bone marrow transplantation or solid organ transplant.
  • 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.
  • Subjects have known psychiatric or substance abuse disorder
  • 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:
  • Known allergy to the investigational drug or excipient
  • 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.
  • 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 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 locations and contacts

2 sites in 1 country.

Ying Liu, MD contact

+86 137 8360 4602

yaya7207@126.com

China2 sites, 2 recruiting

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, Shaanxi

    Yu Yao, MD

    Yu Yao, MD

    Not yet recruiting

  • Ying Liu

    Zhengzhou, Henan

    Ying Liu, MD, +8613783604602, yaya7207@126.com

    Ying Liu, MD

    Recruiting

Other trials in China

About this study

Official title: A Prospective, Randomized Clinical Study of the Prevention or Treatment of Camrelizumab-induced Reactive Cutaneous Capillary Endothelial Proliferation (RCCEP) With Thalidomide

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

Read the 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
Being tested
Camrelizumab, Thalidomide 50mg, Thalidomide 100mg, Thalidomide 200mg, Chemotherapy
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CamrelizumabDrug

    Also called SHR-1210

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

  • Thalidomide 50mgDrug

    Also called Thalidomide

    Thalidomide 50mg，po qd；

  • Thalidomide 100mgDrug

    Also called Thalidomide

    Thalidomide 100mg，po qd；

  • Thalidomide 200mgDrug

    Also called Thalidomide

    Thalidomide 200mg，po qd；

  • ChemotherapyDrug

    Also called Platinum-based chemotherapy

    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.
Study groups in NCT06231680
Study groupRoleWhat they receive
Prevention Cohort 1 Group AExperimentalCamrelizumab + chemotherapy+Thalidomide(50mg)
Receives: Drug: Camrelizumab; Drug: Thalidomide 50mg; Drug: Chemotherapy
Prevention Cohort 1 Group BExperimentalCamrelizumab + chemotherapy+Thalidomide(100mg)
Receives: Drug: Camrelizumab; Drug: Thalidomide 100mg; Drug: Chemotherapy
Treatment Cohort 2 Group AExperimentalThalidomide(100mg)
Receives: Drug: Thalidomide 100mg
Treatment Cohort 2 Group BExperimentalThalidomide(200mg)
Receives: Drug: Thalidomide 200mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence rate of RCCEP

    Incidence rate of RCCEP

    Measured: 2 years

  2. RCCEP response rate at 3 weeks

    RCCEP response rate at 3 weeks

    Measured: 3 weeks

Secondary outcomes (6)

  1. Incidence rate of ≥G3 grade RCCEP

    Incidence rate of ≥G3 grade RCCEP

    Measured: 2 years

  2. Median time to RCCEP

    Median time to RCCEP

    Measured: 2 years

  3. Incidence rate of RCCEP at 6 weeks

    Incidence rate of RCCEP at 6 weeks

    Measured: 6 weeks

  4. Incidence rate of RCCEP at 9 weeks

    Incidence rate of RCCEP at 9 weeks

    Measured: 9 weeks

  5. Median time to response of RCCEP

    Median time to response of RCCEP

    Measured: 2 years

  6. Thalidomide treatment-related adverse events

    Thalidomide treatment-related adverse events

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2024
  2. Study start19 Jan 2024
  3. Primary completion30 Jun 2024 (estimated)
  4. Study completion30 Sep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
132 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06231680
Sponsor's protocol ID
MA-RCCEP-II-001
Status last verified
Jan 2024
First submitted
7 Nov 2023
Last updated
29 Mar 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Camrelizumab, Thalidomide 50mg and Thalidomide 100mg in people with Lung Cancer, Nonsmall Cell and Esophageal Carcinoma, run by Henan Cancer Hospital at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ying Liu, MD (+86 137 8360 4602, yaya7207@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate of RCCEP (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06231680.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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