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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

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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Esophageal Squamous Cell Carcinoma Drug: Anti-PD-1 antibody combined with Paclitaxel and carboplatin. Procedure: Surgical treatment stage Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
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
Official Title: The Exploration of Immunodynamic Monitoring in the Population Evaluation of Neoadjuvant Chemotherapy Immunotherapy in Patients With Solid Tumor of the Chest.
Actual Study Start Date : April 1, 2021
Estimated Primary Completion Date : April 1, 2022
Estimated Study Completion Date : March 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Functional subsets of peripheral CD8 positive T cells [ Time Frame: Approximately 1 years ]
  2. 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.

  3. 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.

  4. 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.


Secondary Outcome Measures :
  1. 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. 2-year survival rate [ Time Frame: up to 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 72 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05044728


Contacts
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Contact: Qiang Fang, PH.D +8618980758305 fq@sichuancancer.org

Locations
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China, Sichuan
Sichuan Cancer Hospital Recruiting
Chengdu, Sichuan, China, 610000
Contact: Qiang Fang    +8618980758305    fq@sichuancancer.org   
Sponsors and Collaborators
Sichuan Cancer Hospital and Research Institute
Investigators
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Principal Investigator: Qiang Fang, PH.D Sichuan Cancer Hospital and Research Institute
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Responsible Party: Qiang Fang,MD, Principal Investigator, Clinical Professor., Sichuan Cancer Hospital and Research Institute
ClinicalTrials.gov Identifier: NCT05044728    
Other Study ID Numbers: CTIO1.0
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Qiang Fang,MD, Sichuan Cancer Hospital and Research Institute:
Anti-PD-1
NSCLC
ESCC
Neoadjuvant
Immune microenvironment
Additional relevant MeSH terms:
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Esophageal Squamous Cell Carcinoma
Neoplasms by Site
Neoplasms
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Paclitaxel
Carboplatin
Antibodies
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs