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

Primary Purpose

Non-small Cell Lung Cancer, Esophageal Squamous Cell Carcinoma

Status

Unknown status

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Anti-PD-1 antibody combined with Paclitaxel and carboplatin.

Surgical treatment stage

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Anti-PD-1, NSCLC, ESCC, Neoadjuvant, Immune microenvironment

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sichuan Cancer HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Neoadjuvant Chemotherapy Immunotherapy stage

Arm Description

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.

Outcomes

Primary Outcome Measures

Functional subsets of peripheral CD8 positive T cells

Overall response rate(ORR)

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)

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)

Assess all adverse events according to the NCI Common Terminology Criteria for (NCI-CTCAE) v 4.0.3.

Secondary Outcome Measures

Progress Free Survival(PFS)

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

Full Information

NCT ID

NCT05044728

First Posted

September 3, 2021

Last Updated

September 5, 2021

Sponsor

Sichuan Cancer Hospital and Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT05044728

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Unknown status

Study Start Date

April 1, 2021 (Actual)

Primary Completion Date

April 1, 2022 (Anticipated)

Study Completion Date

March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sichuan Cancer Hospital and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-small Cell Lung Cancer, Esophageal Squamous Cell Carcinoma

Keywords

Anti-PD-1, NSCLC, ESCC, Neoadjuvant, Immune microenvironment

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

This study is a prospective, single-arm, open cohort study (randomly stratified within the group).

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Neoadjuvant Chemotherapy Immunotherapy stage

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Anti-PD-1 antibody combined with Paclitaxel and carboplatin.

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Surgical treatment stage

Intervention Description

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 Measure Information:

Title

Functional subsets of peripheral CD8 positive T cells

Time Frame

Approximately 1 years

Title

Overall response rate(ORR)

Description

Time Frame

Approximately 1 years

Title

Pathological complete response (pCR)

Description

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.

Time Frame

At time of surgery

Title

Immune Related Adverse Events (irAEs)

Description

Assess all adverse events according to the NCI Common Terminology Criteria for (NCI-CTCAE) v 4.0.3.

Time Frame

Approximately 1 years

Secondary Outcome Measure Information:

Title

Progress Free Survival(PFS)

Description

Time Frame

Approximately 1 years

Title

2-year survival rate

Time Frame

up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

72 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Qiang Fang, PH.D

Phone

+8618980758305

fq@sichuancancer.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Qiang Fang, PH.D

Organizational Affiliation

Sichuan Cancer Hospital and Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Sichuan Cancer Hospital

City

Chengdu

State/Province

Sichuan

ZIP/Postal Code

610000

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Qiang Fang

Phone

+8618980758305

fq@sichuancancer.org

12. IPD Sharing Statement

Learn more about this trial

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

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