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Radiotherapy clinical trials

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NCT ID: NCT06232083 Recruiting - Radiotherapy Clinical Trials

Application of PLDR External Irradiation Combined With Immune Checkpoint Inhibitors in Recurrent Cervical Cancer

Start date: February 1, 2024
Phase: Phase 1/Phase 2
Study type: Interventional

At present, the treatment methods for recurrent cervical cancer are very limited. The immune checkpoint inhibitors (ICBs) is a promising new directions for recurrent cervical cancer, but the clinical response rate is insufficient. Pulse low-dose rate radiotherapy (PLDR) is a new technology in recent years, which uses continuous pulse low-dose rate irradiation to induce hypersensitivity in tumors, and its clinical safety has been verified. Compared to conventional radiotherapy, PLDR has advantages in protecting the lymphatic system and relieving the immune barrier, but it is still unclear whether it can improve the efficacy of ICB. This project aims to combine PLDR with ICB to explore new strategies for recurrent cervical cancer.

NCT ID: NCT06205472 Recruiting - Clinical trials for Hepatocellular Carcinoma

Phase II Study of Adjuvant SIB Radiotherapy Following Narrow-Margin Hepatectomy in Patients With HCC.

Start date: January 26, 2024
Phase: Phase 2
Study type: Interventional

This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of adjuvant simultaneouslyintegrated boost radiotherapy following narrow-margin(<1cm) hepatectomy in patients with HCC. Eligibility patients will receive IMRT or VMAT to high risk area of tumor bed and tumor bed. The prescription dose to 95% GTVtb boost was planned at 55-60Gy, with PTV 45-50Gy, in 23-25 fractions, mainly depending on the dose constraints of OARs. The primary endpoint is the 3-year OS, the secondary endpoints are disease-free survival, patterns of failure, toxic events and local control rate.

NCT ID: NCT06202014 Recruiting - Pancreatic Cancer Clinical Trials

Phase II Study of Concurrent Radiotherapy With Envafolimab and Capecitabine in LAPC

Start date: January 31, 2024
Phase: Phase 2
Study type: Interventional

This is a single-arm prospective phase II clinical trial to investigate the efficacy and safety of concurrent radiotherapy with envafolimab and capecitabine in locally advanced pancreatic cancer.Eligibility patients will receive intensity-modulated radiotherapy(IMRT)or volumetric modulated arc therapy(VMAT) to pancreatic lesions,metastatic lymph nodes and high-risk lymphatic drainage areas,concurrent with and followed by envafolimab and capecitabine.

NCT ID: NCT06201078 Recruiting - Radiotherapy Clinical Trials

Stereotactic Re-irradiation of Local Recurrences of Prostate Cancer After Radiotherapy

PROSTARE
Start date: July 31, 2023
Phase: Phase 2
Study type: Interventional

The goal of this clinical study is to evaluate the toxicity and efficacy of re-irradiation using focal stereotactic body radiotherapy (SBRT) in patients with local recurrence of prostate cancer after definitive or post-operative radiotherapy. The main question is the tolerance of such treatment, concerning the incidence of Grade ≥ 2 and Grade ≥ 3 GU and GI toxicity. Also the efficacy of SBRT will be measured in terms of Biochemical Control. Secondary endpoints include: Biochemical Response, Metastases-Free Survival, Relapse-Free Survial, Overall Survival and patients' reported tolerance measured with Quality of Life questionnaires (QoL C-30 and PR-25). The evaluation of the tolerance and effectiveness of stereotactic radiotherapy (SBRT) will be performed in 3 subgroups: in patients with local recurrence after conventionally fractionated definitive radiotherapy (Group A) or ultrahypofractionated definitive SBRT (Group C) or after prostatectomy and post-operative radiotherapy (Group B). The study group is planned to include 60 patients.

NCT ID: NCT06190782 Recruiting - Clinical trials for Esophageal Squamous Cell Carcinoma

Local Therapy for Oligometastatic ESCC Patients Treated With PD-1 Inhibitor

Start date: September 27, 2022
Phase: Phase 3
Study type: Interventional

Patients with oligometastatic squamous cell carcinoma were enrolled and randomly assigned to receive either PD-1 inhibitor +/- chemotherapy combined with local therapy or PD-1 inhibitor +/- chemotherapy alone. The primary end point was progression-free survival (PFS). The secondary end points included overall survival, side effects and local control.

NCT ID: NCT06142318 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Pirfenidone as a Radiosensitizer in the Treatment of Head and Neck Squamous Cell Carcinoma

Start date: November 15, 2023
Phase: Phase 2
Study type: Interventional

Head and neck squamous cell carcinoma (HNSCC) is the sixth most common cancer worldwide, with a 5-year survival rate of less than 50%. Radiotherapy is an important measure to control tumor recurrence. Although radiotherapy has been widely used in patients with head and neck squamous cell carcinoma, the 2-year local recurrence rate of patients with locally advanced disease is still as high as 50%-60%, and the distant metastasis rate is as high as 20%-30%. This is associated with a lower radiosensitivity in HNSCC. Our previous study has confirmed that type I collagen secreted by cancer-associated fibroblasts (CAFs) can enhance the radioresistance of head and neck squamous cell carcinoma. We also confirmed that pirfenidone could reduce type I collagen expression in CAFs and enhance radiosensitivity in vitro and in vivo. Therefore, we plan to translate the basic research into clinical practice and conduct a prospective interventional phase II clinical trial to investigate the safety and efficacy of pirfenidone as a radiosensitizer in HNSCC.

NCT ID: NCT06120426 Recruiting - Surgery Clinical Trials

En Bloc Resection Versus Separation Surgery Combined With Radiotherapy for the Treatment of Spinal Oligometastatic Tumor.

Start date: July 1, 2023
Phase:
Study type: Observational [Patient Registry]

The purpose of this clinical trial is to explore the impact of En bloc surgery and separation surgery combined with radiation therapy on the prognosis and survival of patients with spinal oligometastatic cancer, describe the clinical results, and optimize future treatment goals

NCT ID: NCT06120127 Recruiting - Colorectal Cancer Clinical Trials

Postoperative Chemotherapy With/Without Radiotherapy and Immunotherapy for Colorectal Liver Metastases With High Risk of Locally Recurrence

IMPROVE
Start date: September 25, 2023
Phase: Phase 2
Study type: Interventional

This study is a randomized controlled phase II trial to evaluate the efficacy of the combination of stereotactic body radiation therapy (SBRT) and immunotherapy with postoperative chemotherapy in colorectal cancer liver metastasis (CRLM) patients with high risk of locally recurrence. Researchers will compare the combination therapy with the postoperative chemotherapy alone to see if postoperative chemotherapy plus SBRT and immunotherapy can further reduce the risk of recurrence and metastasis after surgery.

NCT ID: NCT06100068 Recruiting - Radiotherapy Clinical Trials

HOBBIT 3: Mental Exercises and Temporal Alteration

HOBBIT-META
Start date: November 27, 2023
Phase: N/A
Study type: Interventional

In the HOBBIT-trial by Vakaet et al. A protocol was developed to increase breath-hold time using (voluntary) hyperventilation and oxygenation to achieve DIBH times around 3 minutes. Multiple non-medical interventions are being investigated to prolong a L-DIBH that are feasible in clinical practice. One of these methods will be to alter the time perception of the subjects. It has been noted in multiple studies (both medical and not) that slowing a person's perception of time results in an increase in breath-hold time. This alteration in time perception can be achieved with the use of a slowed clock as well as the usage of mental or physical exercises to preoccupy the subjects. Volunteers will then be randomised into either the standard arm or the intervention arm. The intervention arm will follow standard protocol regarding DIBH preparation, though during the L-DIBH they will be asked to perform a simple mental exercise on a tablet. After 2 sessions of 3 L-DIBHs each, there will be a cross-over to the other arm in order to ascertain comfort and preference with each technique.

NCT ID: NCT06076135 Recruiting - Radiotherapy Clinical Trials

Intestinal Low Dose Radiotherapy Combined With Immunotherapy in Immune-resistant Metastatic Solid Tumors

ILDRV1
Start date: December 26, 2023
Phase: Phase 2
Study type: Interventional

Preclinical and clinical studies have shown that intestinal low dose radiotherapy (ILDR) can enhance antitumor immunity and response to immune checkpoint blockade (ICB) by regulating intestinal flora. Therefore, the investigators design a phase II trial to validate the clinical value of combining ILDR and programmed cell death-1 (PD-1) inhibitors in patients with metastatic malignant solid tumors who have failed immunotherapy. The primary endpoints of this analysis are disease control rate (DCR), progression free survival while receiving second-line therapy (PFS2), and objective response rate (ORR). The secondary endpoints are the incidence of adverse events (AEs) and the overall response rate. This study is a researcher-initiated, prospective clinical study. The target population is patients with advanced metastatic malignant solid tumors who have progressed after immunotherapy. Thirty participants will be enrolled in this study. The primary objective of the study is to evaluate the efficacy and safety of ILDR combined with PD-1 inhibitors in immune-resistant metastatic malignant solid tumors, and the effect of ILDR combined with PD-1 inhibitors on the intestinal flora. Treatment will be given to patients who meet the eligibility criteria after obtaining their written informed consent. Subjects will be allocated into 3 groups. The jejunum and ileum will be selected and performed with low dose radiation of 1Gy/F, 1F/W, 1Gy-3Gy. The immunotherapy regimen is determined by the doctor in charge based on the patient's clinical status, original immunotherapy regimen, radiological findings, and pathological results. Immunotherapy is administered in combination with radiotherapy, with a treatment frequency of once every 3 weeks until progression. Assess the occurrence rates of DCR, PFS2, ORR, and AEs in accordance with the guidelines for response criteria for use in trials testing immunotherapeutics (iRECIST) to determine the extent of benefit for patients participating in this trial. At least one accessible and measurable lesion should be selected as the target lesion for observation. Furthermore, tissue samples, stool samples, and peripheral blood samples will be collected to assess the effect of this treatment on immune status and intestinal flora.