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Esophageal CarcinomaPhase 2CAR-RMECNCT06681285

Cadonilimab Combined With Anlotinib Followed by Radiotherapy in Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (CAR-RMEC)

A Phase 2 study testing Cadonilimab ;Anlotinib in people with Esophageal Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

GLOBOCAN 2020 reported that the global incidence of esophageal cancer climbed to 604,100, accounting for 3.1% of all tumor sites and ranking 7th out of 36 cancers. In addition, about 544,076 new esophageal cancer deaths, which accounted for 5.5% of all study centers and ranked 6th among 36 cancers. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Esophageal Carcinoma
What is being tested?
Cadonilimab ;Anlotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteChina
Study dates
1 Nov 2024to 31 Dec 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • The subjects voluntarily joined the study, signed informed consent, had good compliance, and cooperated with follow-up;
  • Patients with recurrent/metastatic esophageal squamous cell carcinoma were confirmed by pathology or cytology.
  • Age≥18 years old, male or female;
  • Eastern Cooperative Oncology Group（ECOG） score 0-2 points;
  • Patients who have not received systematic treatment for recurrent/metastatic esophageal squamous cell carcinoma or have received systematic treatment failure for recurrent/metastatic esophageal squamous cell carcinoma;
  • According to the solid tumor efficacy evaluation criteria (RECIST version 1.1), there is at least one radiographically measurable lesion;
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  • Expected survival time ≥3 months;
  • There is sufficient organ and bone marrow function, as follows:
  • Hemoglobin (Hb) ≥ 90g/L;
  • Neutrophil count (ANC) ≥ 1.5 × 109/L;
  • Platelet count (PLT) ≥ 100 × 109/L;
  • Serum albumin (ALB) ≥ 30g/L;
  • Alanine transaminase (ALT) and aspartate transaminase (AST) ≤ 2.5 ULN; If there is liver metastasis, ALT and AST should be ≤ 5ULN;
  • Total bilirubin (TBIL) ≤ 1.5ULN;
  • Serum creatinine (Cr) ≤ 1.5ULN or creatinine clearance rate (CCr) ≥ 60ml/min;
  • International normalized ratio (INR) ≤ 1.5, activated partial thromboplastin time (APTT) ≤ 1.5 times ULN;
  • Normal thyroid function is defined as thyroid stimulating hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, subjects with total T3 (or FT3) and FT4 within the normal range can also be enrolled;
  • The myocardial enzyme spectrum is within the normal range (simple laboratory abnormalities that are deemed clinically insignificant by the researchers are also allowed to be included);
  • Echocardiographic evaluation: Left ventricular ejection fraction (LVEF) ≥ lower limit of normal (50%);
  • Women of childbearing age should agree to use contraceptive measures (such as intrauterine devices, birth control pills, or condoms) during the study period and within 6 months after the end of the study; Within 7 days prior to enrollment in the study, the serum or urine pregnancy test must be negative and the patient must be non lactating; Men should agree to use contraception during the study period and for 6 months after the end of the study period for patients

Who cannot join

  • Patients with uncontrolled or symptomatic active central nervous system (CNS) metastases (patients with CNS metastases who have been adequately treated, are clinically stable for at least 2 weeks, and have stopped corticosteroids 1 week prior to enrollment can be enrolled, and patients with asymptomatic BMS who do not require treatment can be enrolled);
  • There is pleural or peritoneal effusion or pericardial effusion that cannot be controlled after effective treatment;
  • Patients with serious concurrent diseases, such as heart failure, high-risk uncontrolled arrhythmias, severe myocardial infarction, refractory hypertension, renal failure (CKD-stage 4 and above), thyroid insufficiency, mental illness, diabetes, severe chronic diarrhea (more than 7 defecation times per day), etc., and who are deemed unsuitable for participation in this clinical study by the researchers;
  • The presence of any active, known or suspected autoimmune disease. Admitted subjects who are in a stable state and do not require systemic immunosuppressive therapy;
  • Any other malignancies developed during the first 3 years of study, except locally treatable and cured basal cell or squamous cell carcinoma of the skin, superficial bladder cancer, carcinoma in situ of the cervix, breast ductal carcinoma in situ, and papillary thyroid cancer
  • human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), untreated active hepatitis (hepatitis B, defined as HBV-DNA≥1000 copies /ml; Hepatitis C, defined as HCV-RNA above the lower detection limit of analytical methods) or co-infection with hepatitis B and hepatitis C;
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  • Imaging during the screening period showed that the tumor surrounded or invaded important blood vessels or organs (such as the heart and pericardium, trachea, aorta, superior vena cava, etc.) or had obvious necrosis and voids, and the researchers determined that entering the study would cause bleeding risk; Subjects at risk for esophagotracheal or esophagopleural fistula；
  • Past or current non infectious pneumonia/interstitial lung disease (including radiation pneumonitis) requiring systemic corticosteroid therapy;
  • Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
  • Individuals who are allergic to the drugs or their components used in this program;
  • Any of the following situations occurred during previous PD-1 inhibitor treatment:
  • Previous occurrence of grade 3 or higher immune-related adverse events(irAE )(excluding endocrine system related irAE) resulting from PD-1 inhibitor therapy, irAE resulting in permanent discontinuation of therapy, grade 2 immune-related cardiotoxicity, or neurological or ocular irAE of any grade.
  • Prior to screening in this study, all adverse events treated with prephase PD-1 inhibitors had not been fully resolved or had not been resolved to grade 1. Subjects with grade 2 or greater endocrine adverse events were admitted if their condition was stable and asymptomatic with appropriate alternative therapy.
  • Prior adverse events requiring immunosuppressant therapy other than glucocorticoids, or recurrent adverse events during prior immunotherapy requiring systemic glucocorticoid therapy;
  • Pregnant or lactating women;
  • with a history of psychiatric drug abuse and can not quit or patients with mental disorders;
  • The researcher thinks that it is not appropriate to participate in this researcher; 15, unwilling to participate in the study or unable to sign the informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wenbin Shen, MD contact

15831183879

wbshen2024@hebmu.edu.cn

Ke Yan, PhD contact

15932664372

yancole@126.com

China1 site

  • Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011

    Wenbin Shen, MD, 15831183879, wbshen2024@hebmu.edu.cn

    Ke Yan, PhD, 15932664372, yancole@126.com

Other trials in China

About this study

Official title: The Efficacy and Safety of Cadonilimab Combined With Anlotinib Followed by Radiotherapy in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (CAR-RMEC):A Single-arm, Multicenter, Phase II Clinical Trial

GLOBOCAN 2020 reported that the global incidence of esophageal cancer climbed to 604,100, accounting for 3.1% of all tumor sites and ranking 7th out of 36 cancers. In addition, about 544,076 new esophageal cancer deaths, which accounted for 5.5% of all study centers and ranked 6th among 36 cancers. Esophageal squamous cell carcinoma (ESCC) is the most common pathological type of esophageal cancer in China, and accounts for about 90% of cases. Immunotherapy has become the main treatment for second-line and later esophageal cancer patients, but because of the single target, limited mediated signaling pathway, and high drug resistance rate, single-target blocking has limited efficacy. Cadonilimab is a novel humanized bispecific antibody targeted by programmed death receptor 1（PD-1）/cytotoxic T-lymphocyte antigen 4 (CTLA-4)，which can simultaneously block the two immune checkpoint pathways of PD-1 and CTLA-4, indirectly "liberating" immune cells, and improving immune efficacy. Anlotinib inhibits tumor angiogenesis by fully acting on the VEGFR/PDGFR/FGFR pathway, while remodeling tumor microenvironment, increasing T cell activity and infiltration, and synergizing immunotherapy. In addition, the control of local tumors or oligometastases by radiotherapy combined with systemic therapy such as immunotherapy has become an important research direction for metastatic esophageal cancer. This study will explore the efficacy and safety of cadonilimab combined with anlotinib sequential radiotherapy for the treatment of recurrent or metastatic esophageal squamous cell carcinoma (ESCC) at second or later line.

Being tested
Cadonilimab ;Anlotinib
Keywords
Cadonilimab, Anlotinib, Radiotherapy, Esophageal carcinoma
Medical subject headings
Esophageal Neoplasms

What participants receive

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

  • Cadonilimab ;AnlotinibDrug

    Cadonilimab Combined With Anlotinib Followed by Radiotherapy in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma

Study groups in NCT06681285
Study groupRoleWhat they receive
Cadonilimab Combined With Anlotinib Followed by Radiotherapy in the Second and Later-line TreatmentExperimentalCadonilimab Combined With Anlotinib Followed by Radiotherapy in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma
Receives: Drug: Cadonilimab ;Anlotinib

What is being measured

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

  1. Assessment of progression-free survival (PFS) in Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma patients receiving Cadonilimab Combined With Anlotinib Followed by Radiotherapy

    PFS is defined as the time from the start of enrollment until tumor progression or death from any cause.

    Measured: 2 years

Secondary outcomes (3)

  1. Assessment of objective remission rate (ORR) in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma patients receiving Cadonilimab Combined With Anlotinib Followed by Radiotherapy

    Objective tumor remission is assessed by the investigator using the Solid Tumor Remission Assessment Criteria (RECIST 1.1 criteria). Objective remission rate (ORR): defined as the proportion of subjects whose tumor volume shrinks to a pre-specified value and can be maintained for the minimum time frame required, incorporating cases in complete remission (CR) and partial remission (PR).

    Measured: 2 years

  2. Assessment of disease control rate (DCR) in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma patients receiving Cadonilimab Combined With Anlotinib Followed by Radiotherapy

    Disease control rate (DCR): the proportion of patients whose tumors shrank or were stable and remained so for a certain period of time, including complete remission (CR), partial remission (PR) and stable disease (SD)

    Measured: 2 years

  3. Assessment of overall survival (OS) in the Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma patients receiving Cadonilimab Combined With Anlotinib Followed by Radiotherapy

    OS is defined as the time from the start of enrollment to death from any cause.

    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 posted8 Nov 2024
  2. Study start1 Nov 2024 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2028 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06681285
Sponsor's protocol ID
2024207
Acronym
CAR-RMEC
Status last verified
Nov 2024
First submitted
1 Nov 2024
Last updated
8 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cadonilimab ;Anlotinib in people with Esophageal Carcinoma, run by Hebei Medical University Fourth Hospital at 1 site 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 20 inclusion and 17 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: opening soon, as of the sponsor's last update on 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Wenbin Shen, MD (15831183879, wbshen2024@hebmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of progression-free survival (PFS) in Second and Later-line Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma patients receiving Cadonilimab Combined With Anlotinib Followed by Radiotherapy (time frame: 2 years). 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 NCT06681285.

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 8 Nov 2024.

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