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Esophageal Squamous Cell CarcinomaPhase 2NCT05650216

Camrelizumab Combined With Neoadjuvant Concurrent Chemoradiotherapy for Resectable Locally Advanced ESCC（NICE-RT）

A Phase 2 study testing Chemotherapy (nab-paclitaxel AUC=2 and carboplatin 80mg/m2)，Immunotherapy (camrelizumab 200mg)、Radiotherapy(primary lesion and adjacent lymph nodes 41.4Gy， distant lymph node 0.5Gy*4) in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Chest Hospital at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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

NICE-RT study is a "safety run-in" and phase II trial evaluating the safety and efficacy of Camrelizumab combined with Nab-paclitaxel and Carboplatin and Radiotherapy in patients with resectable locally advanced esophageal squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Esophageal Squamous Cell Carcinoma
What is being tested?
Chemotherapy (nab-paclitaxel AUC=2 and carboplatin 80mg/m2)，Immunotherapy (camrelizumab 200mg)、Radiotherapy(primary lesion and adjacent lymph nodes 41.4Gy， distant lymph node 0.5Gy*4)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteChina
Study dates
25 Dec 2022to 25 Dec 2024
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Informed consent has been signed.
  • In age from 18 to 75.
  • Thoracic esophageal squamous cell carcinoma confirmed by histology or cytology, which is classified as cT1b-4aN2-3M0 or M1 (only for supraclavicular lymph node metastasis), accompanied by lymph node metastasis (CT shows that the short diameter of the lymph node is greater than 1cm, the lymph node near the recurrent laryngeal nerve is greater than 8mm, the lymph node in the left upper abdominal region of the stomach is greater than 8mm, and PET-CT indicates positive).
  • At least one metastatic lymph node is more than or equal to 5cm from the primary lesion.
  • Have not received any anti-tumor treatment for esophageal cancer in the past, including radiotherapy, chemotherapy, surgery, etc.
  • The investigator assessed that lesion can be removed surgically.
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  • At least one measurable lesion (according to RECIST 1.1)
  • ECOG PS: 0~1.
  • Weight loss<10% within 3 months, PG-SGA score<8.
  • Has sufficient organ function within 28 days before the first administration, (1) Blood routine: WBC≥3.0×109/L; ANC≥1.5×109/L; PLT≥50×109/L; HGB≥90 g/L (2) Liver function: AST≤5.0×ULN; ALT≤5.0×ULN; TBIL≤2.0×ULN (3) Renal function: Cr≤1.5×ULN or CrCl ≥60 mL/min (4) Coagulation function: INR≤1.5; APTT≤1.5×ULN (5)Women of childbearing age must take contraceptive measures within 3 months from the first dose to the last use of the study drug.

Who cannot join

  • 1.Pathological type and stage
  • Pathology indicates that it is mixed squamous cell carcinoma (including adenosquamous carcinoma, squamous cell carcinoma, small cell carcinoma, carcinosarcoma, sarcomatoid carcinoma, etc.)
  • Non resectable or metastatic esophageal cancer
  • 2. Medical history and complications
  • Subjects with any known active autoimmune disease (subjects who have stable clinical symptoms and do not need systematic use of immunosuppressants, such as type I diabetes and hypothyroidism that only need hormone treatment, and skin diseases that do not need systematic treatment can be included).
  • Subjects who have any complications requiring systemic treatment with glucocorticoids such as prednisone (>10mg/day) or who have used immunosuppressive drugs within 14 days before the first administration (subjects who do not have active autoimmune diseases, inhale or locally use glucocorticoids, and who use prednisone (>10mg/day) for hormone replacement treatment of adrenal insufficiency can be included in the group).
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  • Subjects have received tumor vaccine or other immune activated anti-tumor drugs (such as interferon, interleukin, thymosin or immunocyte therapy) within 1 month before the first administration.
  • The subject is participating in other clinical trials or has received drug intervention from other clinical trials within 4 weeks before the first administration.
  • Subjects had received surgery or radiotherapy>30Gy within 4 weeks before the first administration.
  • Subjects with other malignant tumors that need to be treated (subjects with skin basal cell carcinoma, skin squamous cell carcinoma, breast cancer in situ or cervical cancer in situ that have received radical treatment and do not need other treatment can be included)
  • Subjects have suffered from serious cardiovascular diseases in the past: myocardial ischemia or myocardial infarction above Grade II, arrhythmia under poor control (including QTc interval ≥ 480 ms); Grade III-IV cardiac insufficiency; Color Doppler echocardiography showed that left ventricular ejection fraction (LVEF) was less than 50%.
  • Subjects have known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation.
  • Subjects received live vaccine within 30 days before the first administration.
  • 3. Laboratory inspection
  • The subject's serum is HIV positive
  • Active hepatitis B (HbsAg positive and HBV-DNA ≥ 103 copies/mL) or active hepatitis C (HCV antibody positive and HCV-DNA positive, requiring antiviral treatment at the same time).
  • 4. Allergies and adverse drug reactions should be excluded
  • Presence of allergy or hypersensitivity to monoclonal antibodies
  • Allergy or intolerance during infusion
  • 5. Diseases or abnormal laboratory indicators that the investigator believes will affect the research results or are not in line with the interests of the subject should be excluded.

Trial locations and contacts

1 site in 1 country.

Jun Liu, M.D. contact

+862122200000 ext. 3602

drjunliu@qq.com

Xiaolong Fu, M.D. contact

+862122200000 ext. 3602

China1 site

  • Shanghai Chest Hospital

    Shanghai, Shanghai Municipality, 200030

    Jun Liu, M.D.

Other trials in China

About this study

Official title: A Single-arm，Single-center，Phase II Trial of Camrelizumab Combined With Neoadjuvant Concurrent Chemoradiotherapy for Resectable Locally Advanced Esophageal Squamous Cell Carcinoma（NICE-RT）

NICE-RT study is a "safety run-in" and phase II trial evaluating the safety and efficacy of Camrelizumab combined with Nab-paclitaxel and Carboplatin and Radiotherapy in patients with resectable locally advanced esophageal squamous cell carcinoma.

Read the detailed description

Considering that immunotherapy combined with concurrent chemoradiotherapy may have unknown AEs, in order to explore the safety and tolerability of the regimen of camrelizumab combined with nab-paclitaxel and carboplatin and radiotherapy, this study set up an initial "safety run-in" phase. 10 patients will be firstly enrolled, and treatment-related adverse reactions（TRAEs）and surgical complications will be observed at the same time. If the completion rate of neoadjuvant therapy and surgery is greater than 80%, rate of 30-day major complication is less than 20%,and no death, it will continue to enroll 40 patients to explore the efficacy and safety of the regimen. If the completion rate of neoadjuvant therapy and surgery is less than 80%, the MDT will determine whether the study move forward. If treatment related death is more than 1 patients, the study will be terminated.

Being tested
Chemotherapy (nab-paclitaxel AUC=2 and carboplatin 80mg/m2)，Immunotherapy (camrelizumab 200mg)、Radiotherapy(primary lesion and adjacent lymph nodes 41.4Gy， distant lymph node 0.5Gy*4)
Medical subject headings
Esophageal Squamous Cell Carcinoma

What participants receive

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

  • Chemotherapy (nab-paclitaxel AUC=2 and carboplatin 80mg/m2)，Immunotherapy (camrelizumab 200mg)、Radiotherapy(primary lesion and adjacent lymph nodes 41.4Gy， distant lymph node 0.5Gy*4)Drug

    Also called Camrelizumab: ai rui ka, SHR-1210; Nab-paclitaxel: ai yue

    1. Neoadjuvant treatment period: Radiotherapy: Primary lesions and adjacent lymph nodes: The mode of involved field irradiation (IFI) is adopted, no preventive radiation is given. The total dose is 41.4Gy, 1.8Gy/23f. Distal lymph nodes ≥ 5cm away from the primary lesion: low-dose radiotherapy with a total dose of 4Gy, 0.5Gy/8f, Day1 to Day4, Day22 to Day25. Chemotherapy: Carboplatin(AUC=2), Nab-paclitaxel(80mg/m2), Day1/8/15/22/29. Immunotherapy: Camrelizumab(200mg, Day5, Day26).
    2. Perioperative period: Undergo surgery within 4-6 weeks after neoadjuvant therapy
    3. Adjuvant treatment period:

    Camrelizumab: (200mg, Q3W)，continued for up to 1 years，until PD or intolerable toxicity.

Study groups in NCT05650216
Study groupRoleWhat they receive
Immunotherapy combined with ChemoradiotherapyExperimentalA:Chemotherapy: nab-paclitaxel (80mg/m2), carboplatin (AUC=2)，on day 1,8,15,22,29; B:Immunotherapy: camrelizumab (200mg)，IV on days 5 and 26; C:Radiotherapy: Primary lesion and adjacent lymph nodes: 41.4Gy, 1.8Gy/23f; Abscopal lymph node 2Gy, 0.5Gy/4f. D:Ivor-Lewis or McKeown esophagectomy The participants will receive preoperative A+B+C. 4-6 weeks after completion of preoperative therapy ，D will be performed if there is no contraindication.
Receives: Drug: Chemotherapy (nab-paclitaxel AUC=2 and carboplatin 80mg/m2)，Immunotherapy (camrelizumab 200mg)、Radiotherapy(primary lesion and adjacent lymph nodes 41.4Gy， distant lymph node 0.5Gy*4)

What is being measured

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

  1. Safety(The rates of grade 3 and higher-grade treatment-related adverse events)

    Incidence of adverse events using CTCAE 4.03;grade 3 treatment-related adverse events and higher-grade adverse event will be reported

    Measured: From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose

  2. pCR

    pathological complete response (pCR) is defined as disappearance of all invasive cancer after completion of neoadjuvant chemotherapy

    Measured: 12 months

Secondary outcomes (4)

  1. MPR

    major pathologic response (MPR) is defined as residual viable tumor of less than or equal to 10%

    Measured: 12 months

  2. ORR

    objective response rate (ORR) is defined as the proportion of patients with a complete response(CR) or partial response(PR) to treatment according to RECIST v1.1

    Measured: 12 months

  3. EFS

    event-free survival (EFS) is defined as the time after treatment that a group of people in a clinical trial has not had cancer come back or get worse

    Measured: 12 months

  4. OS

    overall survival (OS) is defined as the time from treatment to death, regardless of disease recurrence

    Measured: 12 months

Timeline

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

  1. First posted14 Dec 2022
  2. Study start25 Dec 2022 (estimated)
  3. Primary completion25 Dec 2023 (estimated)
  4. Study completion25 Dec 2024 (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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05650216
Sponsor's protocol ID
NICE-RT
Status last verified
Dec 2022
First submitted
24 Nov 2022
Last updated
14 Dec 2022
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 Chemotherapy (nab-paclitaxel AUC=2 and carboplatin 80mg/m2)，Immunotherapy (camrelizumab 200mg)、Radiotherapy(primary lesion and adjacent lymph nodes 41.4Gy， distant lymph node 0.5Gy*4) in people with Esophageal Squamous Cell Carcinoma, run by Shanghai Chest 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 10 inclusion and 20 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 14 Dec 2022. 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?

Results are not available in the source record.

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

Contact Jun Liu, M.D. (+862122200000 ext. 3602, drjunliu@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety(The rates of grade 3 and higher-grade treatment-related adverse events) (time frame: From date of treatment allocation until surgery was applied during study period or up to at least 90 days after last dose). 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 NCT05650216.

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 14 Dec 2022.

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