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Exploration of Immunodynamic Monitoring in the Population Evaluation of Neoadjuvant Chemotherapy Immunotherapy in Patients With Solid Tumors of the Chest.

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ClinicalTrials.gov Identifier: NCT05044728
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Qiang Fang,MD, Sichuan Cancer Hospital and Research Institute

Tracking Information
First Submitted Date  ICMJE September 3, 2021
First Posted Date  ICMJE September 16, 2021
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE April 1, 2021
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2021)
  • Functional subsets of peripheral CD8 positive T cells [ Time Frame: Approximately 1 years ]
  • Overall response rate(ORR) [ Time Frame: Approximately 1 years ]
    Objective Response Rate is defined as complete response (CR) + partial response (PR), from the beginning of regimental therapy to the end of neoadjuvant therapy, the efficacy of baseline target lesions was assessed by RECIST 1.1 criteria.
  • Pathological complete response (pCR) [ Time Frame: At time of surgery ]
    Pathological complete response is defined as 0% survival of tumor cells in surgically resected tumor samples after neoadjuvant therapy, as assessed by tumor regression grade.
  • Immune Related Adverse Events (irAEs) [ Time Frame: Approximately 1 years ]
    Assess all adverse events according to the NCI Common Terminology Criteria for (NCI-CTCAE) v 4.0.3.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2021)
  • Progress Free Survival(PFS) [ Time Frame: Approximately 1 years ]
    Progress Free Survival is defined as included the development of new metastases, or local progression of metastases or primary lesions that underwent surgical resection and will be assessed according to RESIST 1.1 criteria.
  • 2-year survival rate [ Time Frame: up to 2 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploration of Immunodynamic Monitoring in the Population Evaluation of Neoadjuvant Chemotherapy Immunotherapy in Patients With Solid Tumors of the Chest.
Official Title  ICMJE The Exploration of Immunodynamic Monitoring in the Population Evaluation of Neoadjuvant Chemotherapy Immunotherapy in Patients With Solid Tumor of the Chest.
Brief Summary Chest malignant solid tumor (mainly lung and esophageal cancer) is a common malignant tumor that seriously threatens the health of residents in China. Its morbidity and mortality rank first, sixth, first, and fourth among all malignant tumors respectively. The treatment effect is not satisfactory, and the overall 5-year survival rate after surgery alone is about 20%-35%. Recent studies have shown that neoadjuvant therapy combined with surgery in the treatment of locally advanced esophageal cancer and lung cancer can significantly improve the efficacy compared with surgery alone. The results of multiple international and multi-center neoadjuvant immunotherapy showed that this new model of combined immunoadjuvant immunotherapy brought a breakthrough point for the treatment of malignant solid tumors of the chest. However, its safety and target benefit groups are still the biggest problems, and there is a large room for improvement. To develop the optimal treatment strategy, it is necessary to further clarify the immunomodulatory mechanisms of neoadjuvant CTIO, explore and develop new evaluation methods and prognostic biomarkers for the selection of targeted benefit patients, and the evaluation of efficacy. This is a key scientific issue in the current neoadjuvant CTIO treatment mode for thoracic malignant solid tumors, mainly lung and esophageal squamous cell carcinoma, which urgently needs to solve its safety and select the benefit population.
Detailed Description As a major participant in cellular immunity, CD8-positive T cells are considered to be the main anti-tumor immune effector cells. In addition to producing specific immune responses to viruses and other infections, their functional subsets are closely related to the occurrence and development of major human diseases. Therefore, we have reason to believe that the combination of dynamic monitoring of host immune background and traditional clinical evaluation can effectively clarify the immune background of patients with lung cancer and esophageal squamous cell carcinoma, and provide new ideas and methods for the selection of appropriate immunotherapy regimen and prognosis evaluation. However, the research in this field is still in its infancy.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
This study is a prospective, single-arm, open cohort study (randomly stratified within the group).
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Non-small Cell Lung Cancer
  • Esophageal Squamous Cell Carcinoma
Intervention  ICMJE
  • Drug: Anti-PD-1 antibody combined with Paclitaxel and carboplatin.

    Anti-PD-1 antibody, 240 mg, IV infusion for 30min (not less than 20min and not more than 60min), d1, every 3 weeks for total 2 cycles. Stratified regimen: group A, 24 hours after the end of chemotherapy; Group B will be given immunotherapy on the first day of each cycle.

    Paclitaxel, 135 mg/m2, IV, d1, q3w, for total 2 cycles. Carboplatin, AUC=5 (according to Calvert formula), IV, d1, every 3 weeks for a total of 2 cycles. Stratified regimen: group A, chemotherapy will be given on day 1 of each cycle; Group B will be given chemotherapy drugs 24 hours after the end of immunotherapy.

  • Procedure: Surgical treatment stage
    After the completion of neoadjuvant immunochemotherapy, patients will be tested again for the functional subsets of peripheral CD8 positive T cells. Alternative treatments will be sought for inoperable patients. For patients who are operable will receive minimally invasive or open surgery was performed 1 month after completion of neoadjuvant chemotherapy immunotherapy, and the functional subsets of peripheral CD8 positive T cells were detected again after surgery.
Study Arms  ICMJE Experimental: Neoadjuvant Chemotherapy Immunotherapy stage
Patients with locally advanced non-small cell lung cancer and locally advanced thoracic esophageal squamous cell carcinoma who met the entry and discharge criteria will be enrolled. After detecting the functional subsets of peripheral CD8-positive T cells, the group was randomly stratified 1:1, respectively. Group A received immunotherapy 24 hours after chemotherapy, and group B received chemotherapy 24 hours after immunotherapy.
Interventions:
  • Drug: Anti-PD-1 antibody combined with Paclitaxel and carboplatin.
  • Procedure: Surgical treatment stage
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 5, 2021)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2023
Estimated Primary Completion Date April 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with locally advanced non-small cell lung cancer (stage II or III) and thoracic esophageal squamous cell carcinoma (CT2N1-2M0, CT3-4AN0-2M0).
  • Preoperative biopsy pathology confirmed squamous cell carcinoma or adenocarcinoma with negative driver gene.
  • Without any anti-tumor therapy.
  • Endoscopic examination indicated that the midpoint of the tumor was located in the middle and lower esophageal thoracic segments.
  • Preoperative staging is II or III.
  • Ages 18 to 72 years.
  • Cardiopulmonary, liver and kidney function tests can tolerate surgery.
  • ECOG PS 0-1.
  • Signed the informed consent to participate in the study plan before enrollment.

Exclusion Criteria:

  • Preoperative endoscopic biopsy pathology confirmed small cell carcinoma.
  • Has undergone other anti-tumor therapy.
  • Endoscopic examination indicated that the midpoint of the tumor was located in the upper part of the esophagus.
  • Preoperative examination suggested that T4B was unresectable or distantly metastatic.
  • Corticosteroids or other immunosuppressive drugs were used within 14 days before enrollment. Topical substitute steroids (daily dose ≤10mg) or short-term prescription corticosteroids (≤7 days) were allowed for the prevention or treatment of non-autoimmune diseases.
  • A history of active autoimmune disease or a possible recurrence of autoimmune disease.
  • Severe chronic or active infectious disease.
  • History of interstitial lung disease.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 72 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qiang Fang, PH.D +8618980758305 fq@sichuancancer.org
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05044728
Other Study ID Numbers  ICMJE CTIO1.0
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Qiang Fang,MD, Sichuan Cancer Hospital and Research Institute
Study Sponsor  ICMJE Sichuan Cancer Hospital and Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Qiang Fang, PH.D Sichuan Cancer Hospital and Research Institute
PRS Account Sichuan Cancer Hospital and Research Institute
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP