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
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|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)|
|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|
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.
- 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.
- 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 ]
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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|
- 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.
- 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.
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
|Contact: Qiang Fang, PH.Dfirstname.lastname@example.org|
|Sichuan Cancer Hospital||Recruiting|
|Chengdu, Sichuan, China, 610000|
|Contact: Qiang Fang +8618980758305 email@example.com|
|Principal Investigator:||Qiang Fang, PH.D||Sichuan Cancer Hospital and Research Institute|
|Responsible Party:||Qiang Fang,MD, Principal Investigator, Clinical Professor., Sichuan Cancer Hospital and Research Institute|
|Other Study ID Numbers:||
|First Posted:||September 16, 2021 Key Record Dates|
|Last Update Posted:||September 16, 2021|
|Last Verified:||September 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Esophageal Squamous Cell Carcinoma
Neoplasms by Site
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Squamous Cell
Digestive System Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Antineoplastic Agents, Phytogenic
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs