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Rectal Neoplasms clinical trials

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NCT ID: NCT05651971 Recruiting - Rectal Cancer Clinical Trials

The Anatomical Localization of the Inferior Mesenteric Artery in Relation to the Left Colonic Artery

Start date: November 1, 2022
Phase:
Study type: Observational

1. To observe and measure the distance between the origin of LCA (left colonic artery,LCA) and IMA (inferior mesenteric artery,IMA) root and the distance between IMA and IMV (inferior mesenteric vein,IMV) at the origin of LCA in rectal cancer patients. Statistical analysis of intraoperative measured data, on the basis of the original anatomical relationship, to achieve anatomical localization of quantitative and accurate, for the preservation of LCA laparoscopic radical resection of rectal cancer to provide a strong anatomical basis. 2. The operation time, 253 lymph node dissection time, intraoperative blood loss, postoperative anal exhaust time, postoperative feeding time, postoperative hospital stay, postoperative ischemic colitis rate and postoperative anastomotic leakage rate of patients with laparoscopic radical resection of rectal cancer with preservation of LCA were recorded. The surgical efficacy and clinical significance of laparoscopic radical resection of rectal cancer with preservation of LCA were evaluated.

NCT ID: NCT05646511 Recruiting - Clinical trials for Locally Advanced Rectal Cancer

Total Neoadjuvant Therapy of SCRT+CAPOX vs SCRT+CAPOXIRI for Locally Advanced Rectal Cancer (ENSEMBLE)

ENSEMBLE
Start date: November 21, 2022
Phase: Phase 3
Study type: Interventional

This trial is a multicenter randomized Phase III study to verify the superiority of short-course preoperative radiation (SCRT) and CAPOXIRI over SCRT and CAPOX as preoperative treatments for locally advanced rectal cancer.

NCT ID: NCT05646043 Recruiting - Cancer, Rectum Clinical Trials

PREHAB - Improving Condition Before Surgery

Start date: December 1, 2022
Phase: N/A
Study type: Interventional

The pilot research project is focused on the feasibility of a prehabilitation program for two groups of diagnoses (esophageal and stomach cancer, rectal cancer).

NCT ID: NCT05628038 Recruiting - Clinical trials for Recurrent Rectal Cancer

The Combination of Hypofractionated Radiotherapy and Immunotherapy in Locally Recurrent Rectal Cancer

TORCH-R
Start date: August 18, 2022
Phase: Phase 2
Study type: Interventional

The study is a prospective, single-center, single-arm, two-cohort, phase II clinical trial. Patients aged 18 years or older who had pelvic recurrence rectal cancer with or without resectable distant metastasis, with treatment naive disease (cohort A) or progressive disease after first-line chemotherapy (cohort B), Eastern Cooperative Oncology Group performance status of 0-1, will receive 25-40Gy/5Fx irradiation or 15-30Gy/5Fx reirradiation (pelvic radiation history), 18 weeks toripalimab and investigator's choice of chemotherapy, and stereotactic ablative radiotherapy (SABR) for all metastatic lesions between chemoimmunotherapy cycles, followed by multidisciplinary team (MDT) for decision:follow-up of complete response (CR), radical surgery, sustained treatment of non resection, or exit. The primary endpoint was local objective response rate. Secondary endpoints were extrapelvic objective response rate, R0 resection rate, duration of response, progression-free survival, overall survival, and safety and tolerability of the treatment. Shanghai Junshi Biomedical Technology Co., Ltd. Provides the first three cycles of toripalimab for free and has purchased liability insurance for clinical trial subjects.

NCT ID: NCT05610163 Recruiting - Clinical trials for Locally Advanced Rectal Carcinoma

Testing the Addition of an Anti-Cancer Drug, Irinotecan, to the Standard Chemotherapy Treatment (FOLFOX) After Long-Course Radiation Therapy for Advanced-Stage Rectal Cancers to Improve the Rate of Complete Response and Long-Term Rates of Organ Preservation

JANUS
Start date: December 8, 2022
Phase: Phase 2
Study type: Interventional

This phase II trial compares the effect of irinotecan versus oxaliplatin after long-course chemoradiation in patients with stage II-III rectal cancer. Combination chemotherapy drugs, such as FOLFIRINOX (fluorouracil, irinotecan, leucovorin, and oxaliplatin), FOLFOX (leucovorin, fluorouracil, oxaliplatin, and irinotecan ), and CAPOX (capecitabin and oxaliplatin) work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. FOLFOX or CAPOX are used after chemoradiation as usual treatment for rectal cancer. Giving FOLFIRINOX after chemoradiation may increase the response rate and lead to higher rates of clinical complete response (with a chance of avoiding surgery) compared to FOLFOX or CAPOX after chemoradiation in patients with locally advanced rectal cancer.

NCT ID: NCT05601505 Recruiting - Clinical trials for Circulating Tumor DNA

Circulating Tumor DNA-guided Neoadjuvant Treatment Strategy for Locally Advanced Rectal Cancer

CINTS-R
Start date: November 1, 2022
Phase: Phase 2
Study type: Interventional

Rectal cancer still remains one of the most popular tumors, however, distance metastasis still remains as high as 30% and the long-term survival outcomes are still unsatisfying. The recent conception of total neoadjuvant therapy and immune therapy is becoming popular and the oncologic effects are encouraging, especially in terms of circulating tumor DNA (ctDNA), the prognostic value of ctDNA has been demonstrated by our prior study. This study will carry out accurate ctDNA-guided neoadjuvant therapy on the basis of previous studies of the research group, and give appropriate treatment plans and treatment intensity to patients with different disease degrees. At the same time, combined with the latest progress in clinical diagnosis and treatment, the potential beneficiaries of immunotherapy were screened scientifically, and the combined immunotherapy was implemented accordingly.

NCT ID: NCT05591534 Recruiting - Clinical trials for Locally Advanced Rectal Carcinoma

Endorectal Brachytherapy for Rectal Cancer

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

The management of rectal cancers has changed over the past decades towards a multidisciplinary strategy, combining radiotherapy, chemotherapy, and surgery. Local recurrence rates, dropped to less than 6 % with pre-operative radiotherapy and the standardization of total mesorectal excision (TME), at the price of increased peri-operative morbidity and functional sequelae. Since neoadjuvant treatment achieves up to 30 % complete response, organ preservation has been increasingly debated for good responders. With the introduction of better-quality imaging for tumour visualization and treatment planning, a new targeted radiation treatment was introduced with high dose rate endorectal brachytherapy (HDRBT), developped by Dr Te Vuong's team in Montreal. This treatment allows for radiotherapy dose escalation to increase the complete response rate, and subsequently the rate of patients amenable to rectal preservation. This phase 2 trial study is proposed to assess the feasibility of HDR brachytherapy after standard chemoradiotherapy among patients selected for rectal preservation.

NCT ID: NCT05572684 Recruiting - Lung Cancer Clinical Trials

A Safety, Tolerability and Efficacy Study of NC410 Plus Pembrolizumab in Participants With Advanced Unresectable or Metastatic Solid Tumors

Start date: October 6, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is an open-label, non-randomized, Phase 1b/2 study to determine the safety and tolerability of NC410 when combined with a standard dose of pembrolizumab. This study will also assess the clinical benefit of combination therapy in participants with advanced unresectable and/or metastatic ICI refractory solid tumors OR ICI naïve MSS/MSI-low solid tumors

NCT ID: NCT05563922 Recruiting - Rectal Cancer Clinical Trials

Organ Preservation Strategy of Total Neoadjuvant Chemoradiotherapy for Low Rectal Carcinoma

OP-TNT
Start date: September 1, 2022
Phase: Phase 2
Study type: Interventional

This study aims to evaluate the efficacy and safety of an organ-sparing strategy after neoadjuvant chemoradiotherapy followed by transanal endoscopic microsurgery (TEM) or endoscopic local resection for early low rectal cancer(cT 1-3N0M0).Besides, the clinical complete response rate and near-clinical complete response rate, organ preservation rate, local recurrence rate, distant metastasis rate and quality of life (QoL) will also be assessed.

NCT ID: NCT05555888 Recruiting - Clinical trials for Early Low Rectal Cancer

The Combination of Immunotherapy and Neoadjuvant Short-course Radiotherapy in Early Rectal Cancer (TORCH-E)

TORCH-E
Start date: December 12, 2022
Phase: Phase 2
Study type: Interventional

The study evaluates the combination of immunotherapy of PD-1 antibody and neoadjuvant short-course radiotherapy in early low rectal cancer. A total of 34 patients will receive 5*5Gy short-course radiotherapy, followed by 4 cycles of capecitabine plus oxaliplatin (CAPOX) chemotherapy and PD-1 antibody, finally receive the local excision(TEM) or total mesorectal excision (TME). The rate of complete response (CR, pCR + sustained cCR for ≥ 1 year), Organ retention rate, long-term prognosis, and adverse effects will be analyzed.