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Neoadjuvant Chemotherapy clinical trials

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NCT ID: NCT05554276 Recruiting - Cervical Cancer Clinical Trials

Neoadjuvant Chemotherapy Combined With PD-1 + Radical Radiotherapy in Locally Advanced Cervical Cancer

PD-1
Start date: August 1, 2023
Phase: Phase 2
Study type: Interventional

Based on various external factors and differences in the basic characteristics of patients, in my country, it is not clear whether concurrent chemoradiotherapy can achieve optimal therapeutic effect in patients with pathologically diagnosed stage IIB or above locally advanced cervical cancer. Under the limitations of radiotherapy and surgery conditions in the region, some patients will try neoadjuvant chemotherapy combined with PD-1 antibody therapy before standard radiotherapy, hoping to reduce cancer focus and reduce infiltration. Thereby reducing the scope of radiotherapy, better ensure the efficacy of late radiotherapy and chemotherapy and reduce the side effects of radiotherapy. Judging from the review of such patients, neoadjuvant chemotherapy combined with PD-1 antibody therapy + radical radiotherapy seems to have certain efficacy and tolerance in the near future as expected. No statistical analysis has been done on the long-term survival of patients. This topic intends to treat inoperable locally advanced cervical cancer patients with neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy, and explore the treatment-related toxic and side effects and efficacy of neoadjuvant chemotherapy combined with PD-1 antibody + radical radiotherapy. It is hoped that through this study, it will provide a reference for the comprehensive treatment of inoperable locally advanced cervical cancer that has been pathologically diagnosed in the future.

NCT ID: NCT05529940 Not yet recruiting - Clinical trials for Neoadjuvant Chemotherapy

NeoFOL-R Trial (Perioperative Versus Adjuvnat FOLFIRINOX in Resectable Pancreatic Cancer)

Start date: September 2023
Phase: Phase 3
Study type: Interventional

Rationale: Adjuvant chemotherapy after surgery significantly improved the survival of PC patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early diseases status and improve the R0 resection rate. In addition, it prevents futile surgery by selecting patients with rapid progression of disease. Furthermore, compared to chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. Asians differ from Westerners not only in racial differences, but also in average size and body surface area. Accordingly, there is an urgent need for clinical studies on the dose, toxicity, dosing cycle, and efficacy of anticancer drugs that reflect actual clinical trials in Asian countries for Asians. There are still few studies worldwide that prospectively explored the efficacy of neoadjuvant chemotherapy in resectable PC and the administration of neoadjuvant therapy in resectable PC depends on individual clinical judgment. Therefore, systematic and prospective clinical trials are essential to standardize treatment protocol in resectable PC. Obective: To investigate whether 6 cycles of preoperative mFOLFIRINOX - surgery - 6 cycles of postoperative mFOLFIRINOX improves overall survival by intention-to-treat compared to surgery followed by 12 cycles of postoperative mFOLFIRINOX. Study design: open-label, multicenter, randomized, phase 3 clinical trial Study population: Patients with resectable pancreatic cancer and ECOG performance 0 or 1. Intervention: Invervention arm : 6 cycles of neoadjuvant mFOLFIRINOX followed by surgical resection and 6 cycles of adjuvant mFOLFIRINOX Comparator arm : surgical resection followed by 12 cycles of adjuvant mFOLFIRINOX Primary endpoint: 2-year overall survival rate by intention-to-treat

NCT ID: NCT05522985 Recruiting - Clinical trials for Head and Neck Squamous Cell Carcinoma

Neoadjuvant Chemotherapytreatment of Locally Advanced Head and Neck Squamous Cell Carcinoma

Start date: November 7, 2021
Phase: Phase 2
Study type: Interventional

The objective of research is to evaluate the efficacy and safety of treprizumab injection combined with AP regimen in the treatment of resectable locally advanced head and neck squamous cell carcinoma.122 patients were randomly divided into two groups: the test group (treprizumab injection combined with AP protocol) and the control group (TP protocol); The patients in both groups were treated with three cycles of induction therapy. After the induction therapy, the patients were evaluated and followed up with surgery.

NCT ID: NCT05503108 Suspended - Clinical trials for HER2-negative Breast Cancer

Fasting Mimicking Diet Program to ImpRovE ChemoTherapy in Hormone Receptor Postive (HR+), HER2- Breast Cancer

DIRECT-2
Start date: March 17, 2023
Phase: Phase 3
Study type: Interventional

In preclinical research, short-term fasting (STF) protects tumor-bearing mice against the toxic effects of chemotherapy, improves the CD8+ effector T-cell intratumor infiltration, while enhancing the chemotherapy efficacy. Short-term use of a "fasting-mimicking diet" (FMD) caused a major increase in the efficacy of cancer treatment in mice comparable to STF. In humans, the investigators recently performed a multicenter randomized phase II trial showing that patients with Human Epidermal growth factor Receptor 2 (HER2) negative breast cancer treated with neoadjuvant chemotherapy and FMD displayed a better radiological response and a better pathological response (90-100% vs <90% tumor cell reduction) than patients treated with chemotherapy without FMD (de Groot, Nat Commun 2020; NCT02126449). Therefore these findings will be validated in a phase 3 trial with the underlying hypothesis that FMD during neoadjuvant chemotherapy for breast cancer improves clinical outcomes, potentially due to improved local immunity.

NCT ID: NCT05367206 Recruiting - Cervical Cancer Clinical Trials

Neoadjuvant Chemotherapy Followed by Chemoradiation Versus Chemoradiation for Stage IIIC Cervical Cancer Patients: A Randomized Phase III Trial

N6C
Start date: March 14, 2022
Phase: Phase 3
Study type: Interventional

Evaluate the efficacy and safety of neoadjuvant chemotherapy (NAC) with albumin-bound paclitaxel and carboplatin followed by chemoradiation therapy (CRT) for stage IIIC cervical cancer patients with carcinoma >4 cm in greatest dimension and/or lymph node >2cm in short axis.

NCT ID: NCT05246020 Recruiting - Clinical trials for Neoadjuvant Chemotherapy

Efficacy of Neoadjuvant Hyperthermic Intraperitoneal Chemotherapy in Advanced High-grade Serous Ovarian Cancer (the NHIPEC Trial)

NHIPEC
Start date: December 1, 2020
Phase: Phase 2
Study type: Interventional

Background: Neoadjuvant chemotherapy (NACT) is an important treatment option for patients with ovarian cancer. Although intravenous NACT can improve optimal resection rates and decrease surgical morbidity and mortality, these advantages do not translate into a survival benefit. Ovarian carcinoma is mainly confined to the peritoneal cavity, which makes it a potential target for hyperthermic intraperitoneal chemotherapy (HIPEC). Our previous study showed that HIPEC could be used in the neoadjuvant setting, which was named neoadjuvant HIPEC (NHIPEC). Since hyperthermia is an excellent chemosensitiser, we hypothesised that the combination of NHIPEC and intravenous NACT could show superior efficacy to intravenous NACT alone. Methods: This study is a single-centre, open-label, randomised (1:1 allocation ratio) phase 2 trial. A total of 80 patients will be randomly assigned into an experimental group (NHIPEC+intravenous NACT) or a control group (intravenous NACT). Patients in the experimental group will receive NHIPEC following laparoscopic evaluation, and four tubes will be placed via the laparoscopic ports, which will be used to administer NHIPEC. Then, perfusion with docetaxel (60-75 mg/m2) will be performed (43°C for 60 min, Day 0) followed by cisplatin (75 mg/m2, Day 1) infusion (43°C for 60 min) 24 hours later. After NHIPEC, two cycles of intravenous NACT will be given. Patients in the control group will receive three cycles of intravenous NACT. The primary endpoint is the proportion of patients who achieve a Chemotherapy Response Score (CRS) of 3 according to the CRS system. The secondary endpoints include progression-free survival, overall survival and the rates of complete resection and NHIPEC-related adverse events.

NCT ID: NCT05202314 Recruiting - Colorectal Cancer Clinical Trials

Camrelizumab Combined With Neoadjuvant Chemotherapy After Stent Placement for Left-Sided Obstructive Colonic Cancer

NACSOC-02
Start date: December 12, 2021
Phase: N/A
Study type: Interventional

Patients with obstruction are associated with worse oncologic outcomes compared with those having nonobstructive tumors. Conventionally, patients with malignant large bowel obstruction receive emergency surgery, with morbidity rates of 30%-60% and mortality rates of 7-22%, and about two-thirds of such patients end up with a permanent stoma. Self-expanding metallic stents (SEMS) haven been used as a bridge to surgery (to relieve obstruction prior to elective surgery) in patients with potentially resectable colorectal cancer. Several clinical trials demonstrate that SEMS as a bridge to surgery may be superior to emergency surgery considering the short-term outcomes. SEMS is associated with lower morbidity and mortality rate, increased primary anastomosis rate, and decreased stoma creation rate. Although about half of patients can achieve primary anastomosis after stent placement, the primary anastomosis rate is still significantly lower compared with nonobstructing elective surgery. The interval between stent placement and surgery may be not long enough that bowel decompression is insufficient at the time of operation. Furthermore#the long-term oncologic results regarding SEMS as a bridge to surgery are still limited and contradictory. Sabbagh et al. suggest worse overall survival of patients with SEMS insertion compared with emergency surgery, the 5-year cancer-specific mortality was significantly higher in the SEMS group (48% vs 21%, respectively, P=0.02). One interpretation is that tumor cells may disseminate during the procedure of colonic stenting placement. Immunotherapy has proven to be highly effective as first-line treatment of metastatic colorectal cancer (CRC). And immunotherapy also has emerged as a neoadjuvant approach, possibly changing treatment strategy for both primary resectable and metastatic CRC. We hypothesis that, regardless of the MSI state, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with chemotherapy after stenting may improve overall survival by eradicating micrometastasis. Moreover, immunotherapy (Camrelizumab, an anti-PD-1 antibody) combined with neoadjuvant chemotherapy prolongs the interval between stent placement and surgery, and the time for bowel decompression is more sufficient, which may increase the success rate of primary anastomosis and decrease risk of stoma formation, and furthermore, improve OS and PFS.

NCT ID: NCT05189028 Recruiting - Cervical Cancer Clinical Trials

Study of Neoadjuvant Chemotherapy Versus Definite Concurrent Chemoradiotherapy for Locally Advanced Bulk Cervical Cancer

Start date: July 1, 2021
Phase: Phase 3
Study type: Interventional

This phase III randomized prospective clinical study was conducted to compare the short-term and long-term outcomes of gemcitabine and cisplatin neoadjuvant chemotherapy versus definite cisplatin weekly concurrent chemoradiotherapy in patients with locally advanced bulk cervical cancer.

NCT ID: NCT05092763 Recruiting - Ovarian Cancer Clinical Trials

Prehabilitation During the Neoadjuvant Window of Opportunity in Older Women With Ovarian Cancer

FIT4SURGERY
Start date: December 10, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effectiveness of a home-based, patient-tailored intervention, FIT4SURGERY, to promote physical activity among women with ovarian cancer undergoing neoadjuvant chemotherapy.

NCT ID: NCT05018182 Recruiting - Clinical trials for Neoadjuvant Chemotherapy

FOLFOXIRI for Neoadjuvant Treatment of High-risk Locally Advanced Colorectal Cancer

Start date: August 2, 2021
Phase: Phase 2
Study type: Interventional

The main cause of recurrence after surgical treatment of colorectal cancer is distant metastasis. Neoadjuvant chemotherapy has potential benefits of improving the effectiveness of chemotherapy. Preoperative chemotherapy may eradicate microscopic metastatic cancer cells earlier than adjuvant chemotherapy, reduce cancer cell spillage during surgery, and lessen the invasiveness of surgical resection. The FOLFOXIRI regimen has been shown to have a high objective efficiency in advanced colorectal cancer. This phase II trial is to explore the pathological remission rate and safety of stage II/III locally advanced colon cancer with high risk of recurrence to FOLFOXIRI regimen of neoadjuvant chemotherapy alone.