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Neoadjuvant Chemotherapy clinical trials

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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.

NCT ID: NCT04922853 Recruiting - Rectal Cancer Clinical Trials

Comparison of the Pathological Effect Between 2 and 4 Cycles Neoadjuvant CAPOX for Low/Intermediate Risk II/III Rectal Cancer

COPEC
Start date: August 26, 2021
Phase: Phase 3
Study type: Interventional

To compare the pathological effect between 2 cycles and 4 cycles of Capox regimen as neoadjuvant chemotherapy for low/ intermediate risk stage II/III rectal cancer.

NCT ID: NCT04885270 Recruiting - Clinical trials for Neoadjuvant Chemotherapy

Paclitaxel i.v. Plus Cisplatin i.p for NACT in Patients With Advanced Ovarian Cancer

Start date: August 4, 2021
Phase: Phase 3
Study type: Interventional

To test the effect of intravenous paclitaxel plus intraperitoneal cisplatin for neo-adjuvant chemotherapy in patients with advanced ovarian cancer, the investigators conducted a phase III single arm clinical trial. Included patients will receive interval debulking surgery after 2-6 cycles neoadjuvant chemotherapy based on the clinical judgment of the gynecologic oncologist. Six cycles of chemotherapy will conducted after surgery. And the neoadjuvant chemotherapy is as follows: paclitaxel 135 mg/m2 i.v. and cisplatin 75 mg/m2 i.p. on day 1. The primary end point is optimal debulking rates. the investigators also will evaluate effect on parameters of volume of ascites, tumor size, duration of surgery, hemorrhage, hospitalizations and postoperative complication etc. After comparing with data published online, the investigators will try to find out if paclitaxel i.v. plus cisplatin i.p. is a superior neoadjuvant chemotherapy for advanced ovarian carcinoma.

NCT ID: NCT04815408 Recruiting - Ovarian Cancer Clinical Trials

PD-1 Antibody Combined Neoadjuvant Chemotherapy for Ovarian Cancer

Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to validate the efficacy and safety of anti-PD-1 in combination with neoadjuvant chemotherapy in women with advanced ovarian cancer.

NCT ID: NCT04813523 Recruiting - Clinical trials for Neoadjuvant Chemotherapy

Pembrolizumab Plus Neoadjuvant Chemotherapy for Locally Advanced EGJ Adenocarcinoma

KEYSTONE-003
Start date: April 1, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to observe and evaluate the efficacy and safety of pembrolizumab plus cisplatin and 5-fluorouracil (5-FU) followed Surgery for locally advanced adenocarcinoma of esophagogastric junction

NCT ID: NCT04576143 Recruiting - Clinical trials for HER2-negative Breast Cancer

Efficacy and Safety of Dose-dense Chemotherapy (ddEC-ddP) for Neoadjuvant Chemotherapy of HER2-negative Breast Cancer

Start date: September 20, 2020
Phase: Phase 2/Phase 3
Study type: Interventional

Recent clinical studies showed that breast cancer patients especially for those with lymph node metastasis may benefit from dose-dense chemotherapy, like adriamycin and cyclophosphamide (AC) q2w×4→ paclitaxel (P) q2w×4. However, the studies on dose-dense (dd) regimen chemotherapy is mostly based on postoperative adjuvant chemotherapy and the optimum of dose-dense chemotherapy has not been determined for Chinese population with HER2-negative breast cancer patients. In our study, a prospective, randomized, open-label, multi-center clinical study was conducted to compare the efficacy and safety of dose-dense chemotherapy regimen (dd epirubicin/cyclophosphamide (EC) followed by dd paclitaxel (P)) and conventional chemotherapy (epirubicin/cyclophosphamide (EC) followed by docetaxel (T)) as preoperative neoadjuvant chemotherapy in the treatment of HER2-negative breast cancer in Chinese population.

NCT ID: NCT04061278 Recruiting - Clinical trials for Nasopharyngeal Carcinoma

A Multicenter, Prospective, Phase III Randomized Controlled Clinical Study for the Treatment of N2-3 Nasopharyngeal Carcinoma Patients

Start date: August 1, 2019
Phase: Phase 3
Study type: Interventional

At the initial diagnosis of locally advanced nasopharyngeal carcinoma, a considerable proportion of patients have developed distant metastasis, forming subclinical lesions. Nowadays, with the advent of intensity modulated radiotherapy, the local-regional area is under well controlled. However, distant metastasis is still the main cause of failure in treatment of stage N2-3 nasopharyngeal carcinoma.The severe toxicity of synchronous chemotherapy and the dose intensity of single drug is not enough to effectively control existing subclinical lesions. Neoadjuvant chemotherapy with sufficient intensity (four cycles) can possible effectively kill subclinical lesions prior to the initiation of concurrent chemoradiotherapy, thereby reducing distant metastasis of stage N2-3 nasopharyngeal carcinoma. Meanwhile, four cycles of chemotherapy have been shown to be well tolerated in other tumors. In conclusion, 4-cycle neoadjuvant chemotherapy in combination with radiotherapy is expected to further control the distant metastasis rate of N2-3 nasopharyngeal carcinoma and improve the survival rate.