Neoplasms

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Lung Neoplasms

Esophageal 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

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Carboplatin

Antibodies

Immunomodulating Agents

Immunoglobulins

Tubulin Modulators

Antimitotic Agents

Immunologic Factors

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.

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.

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

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.

Surgical treatment stage

Qiang Fang, PH.D

Qiang Fang

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.

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.

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

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

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

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 is defined as 0% survival of tumor cells in surgically resected tumor samples after neoadjuvant therapy, as assessed by tumor regression grade.

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

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.

Sichuan Cancer Hospital and Research Institute

Principal Investigator, Clinical Professor.

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Pemetrexed

Cisplatin

Participants receive totally 3-4 cycles of toripalimab combined with platinum-based chemotherapy neoadjuvant treatment during preoperative period. After the last treatment (Day 21 of Cycle 4), surgery will be performed within 4-6 weeks. Postoperatively, a comprehensive evaluation will be conducted by the investigator, and the intention was to receive maintenance therapy within 6-12 weeks of the MDT assessment.

Toripalimab will be administered at a fixed dose of 80 mg (2ml)/vial, IV, D1, with a full dose of 240 mg at one time, every 3 weeks for 3-4 cycles. Squamous cell carcinoma will be combined with cisplatin/carboplatin and Nab-paclitaxel: carboplatin, AUC=5, D1, IV, q3w, or cisplatin, 75 mg/m2, IV, q3w, and Nab-paclitaxel, 130 mg/m2, D1, IV, q3w, for 3-4 cycles. Non-squamous cell carcinoma will be combined with cisplatin/carboplatin and Pemetrexed, cisplatin/carboplatin is the same as above, Pemetrexed will be given at 500 mg/m2, D1, IV, q3w, for 3-4 cycles.

Toripalimab in Combination With Platinum-based Chemotherapy

After the last treatment (Day 21 of Cycle 4), surgery was performed within 4-6 weeks.

Postoperatively, a comprehensive evaluation will be conducted by the investigator, and the intention will receive maintenance therapy within 6-12 weeks of the MDT assessment. Toripalimab: a fixed dose of 80 mg (2ml)/vial, IV, D1, a full dose of 240 mg at one time, every 3 weeks administered until PD or intolerable toxicity, for a maximum duration of 1 year.

Adjuvant treatment stage

Jie Lei, PH.D

Tao Jiang, PH.D

In recent years, immune checkpoint inhibitors targeting cytotoxic T-lymphocyte antigen-4, programmed death-1, and programmed death-ligand 1 have achieved milestones in the treatment of NSCLC, from back-line to first-line, and beyond. Is changing the standard of care for NSCLC. Currently, several phases Ⅲ clinical studies of neoadjuvant immunity combined with standard chemotherapy are underway, suggested that neoadjuvant ICI therapy is a promising way for locally advanced lung cancer. As an intermediate state in the process of tumor metastasis, Oligometastatic NSCLC patients have a better prognosis and more likely to benefit from local treatment than patients with extensive distant metastasis. However, there have been few reports of salvage surgery after ICI treatment in Oligometastatic NSCLC, and only one case has been reported to date. There is therefore a need to further gather evidence on salvage surgery after ICI.

This is a single-center, single-arm, prospective phase II study to evaluate the efficacy and safety of toripalimab in combination with platinum-based and surgery in patients with mutation-negative stage IV Oligometastatic NSCLC.

Single-arm, sigle-center, prospective phase II study.

Toripalimab in Combination With Platinum-based Chemotherapy for Mutation-negative Stage IV Oligometastatic NSCLC

Toripalimab in Combination With Platinum-based Chemotherapy in Patients With Mutation-negative Stage IV Oligometastatic NSCLC: A Phase II Study.

Progress Free Survival is defined as included the development of new metastases, or local progression of metastases or primary lesions that underwent surgical resection/radiotherapy and will be assessed according to RESIST 1.1 criteria.

Pathological complete response is defined as 0% survival of tumor cells in surgically resected primary and metastatic tumor samples (excluding brain and bone metastases) after neoadjuvant therapy, as assessed by tumor regression grade.

Main pathology rate is defined as survival of tumor cells ≤ 10% in surgically resected primary and metastatic tumor samples (excluding brain and bone metastases) after neoadjuvant therapy, assessed by tumor regression grade.

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 (primary + metastatic) was assessed by RECIST1.1 criteria.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Exploration of Immunodynamic Monitoring in the Population Evaluation of Neoadjuvant Chemotherapy Immunotherapy in Patients With Solid Tumors of the Chest.	NCT05044728	Non-small Cell ... Esophageal Squa...	Anti-PD-1 antib... Surgical treatm...	18 Years - 72 Years	Sichuan Cancer Hospital and Research Institute
Toripalimab in Combination With Platinum-based Chemotherapy for Mutation-negative Stage IV Oligometastatic NSCLC	NCT05055583	NSCLC Stage IV Oligometastasis	Toripalimab in ... Surgical treatm... Adjuvant treatm...	18 Years - 70 Years	Tang-Du Hospital

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