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

NCT05650216 | Unknown Phase 2

• 1 other identifier: NICE-RT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

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

• pCR

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

  12 months

Secondary Outcomes (4)

• MPR

  12 months

• ORR

  12 months

• EFS

  12 months

• OS

  12 months

Study Arms (1)

Immunotherapy combined with Chemoradiotherapy

EXPERIMENTAL

A: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.

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)

Interventions

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

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.

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

Immunotherapy combined with Chemoradiotherapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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
• \. 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).
• 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.
• \. Laboratory inspection
• The subject's serum is HIV positive

Sponsors & Collaborators

• Shanghai Chest Hospital: lead

Study Sites (1)

Shanghai Chest Hospital

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Drug Therapy; Carboplatin; camrelizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Coordination Complexes; Organic Chemicals

Study Officials

• Jun Liu, M.D.

  Shanghai Chest Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jun Liu, M.D.

CONTACT

+862122200000; drjunliu@qq.com

Xiaolong Fu, M.D.

CONTACT

+862122200000

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: November 24, 2022
• First Posted: December 14, 2022
• Study Start: December 25, 2022
• Primary Completion: December 25, 2023
• Study Completion: December 25, 2024
• Last Updated: December 14, 2022

Record last verified: 2022-12

Locations

CN (1)