Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Preoperative short-course radiotherapy with local boost ,the dose of radiotherapy is PTV-CTV 25Gy/5F with local boost of PTV-GTV 30Gy/5F.

TME surgery after radiotherapy.

Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F without local boost.

TME surgery after radiotherapy.

Except the clinical target volume(CTV),a gross tumour volume（GTV）is delineated，and give a dose of PTV-GTV:30Gy/5F

preoperative short-course radiotherapy with local boost

Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F

preoperative short-course radiotherapy without local boost

both study group and control group received surgery under TME principle after radiotherapy

TME surgery

Fuxiang Zhou, professor

Ling Xia, doctor

A randomized trial comparing weather preoperative short-course radiotherapy with local boost is better than conventional preoperative short-course radiotherapy for local advanced rectal cancer.

The study plans to recruit 100 patients,randomized into study group and control group,patients in study group are given the dose of PTV(planned target volume)-CTV(clinical target volume) 25Gy/5F with a local boost of PTV-GTV(gross tumour volume) 30Gy/5F；patients in control group are given the dose of PTV-CTV 25Gy/5F without a local boost. The other inventions are the same during the whole treatment,after the radiotherapy,they will receive a surgery under TME((total mesorectal excision) principal.Comparing the toxicity of radiotherapy, R0 resection rate,pathological complete remission rate, complications of operation and sphincter retention rate of these two groups to find out weather local boost bringing benefits to patients with local advanced rectal cancer.

Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer

Preoperative Short-course Radiotherapy With Local Boost Versus Conventional Preoperative Short-course Radiotherapy for Rectal Cancer

Zhongnan Hospital

professor

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Capecitabine

Immunomodulating Agents

Oxaliplatin

Immunoglobulins

Antimetabolites

Participants will receive 5\*5Gy node-sparing short-course radiation (radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) concurrently with total neoadjuvant CAPOX and sintilimab regimens: Oxaliplatin, 130mg/m2, intravenous infusion,d1 of each cycle; Capecitabine, 1000mg/m2, PO, BID, d1-14 and sintilimab, 200mg intravenous infusion d1 of each cycle. CAPOX and sintilimab are repeated every 3 weeks for 8 cycles. Patients with cCR will be managed with a WW strategy, and patients who did not achieve cCR will receive TME surgery.

Interventions:

* Radiation: node-sparing short-course radiation
* Drug: PD-1 antibody (Sintilimab)
* Drug: Capecitabine
* Drug: Oxaliplatin

5Gy\*5d, radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes

node-sparing short-course radiotherapy

200mg intravenous infusion d1 of each cycle\*8cycles

Sintilimab

1000mg/m2, PO, BID, d1-14 of each cycle\*8cycles

130mg/m2, intravenous infusion,d1 of each cycle\*8cycles

laparoscopic or robotic TME surgery for non-cCR patients

watch and wait

jinlin du, master

cheng cai, master

Cheng Cai, master

Jinlin Du, master

phase II clinical trial to evaluate node-sparing short-course radiation combined with total neoadjuvant CAPOX and Sintilimab for MSS locally advanced rectal cancers.

This is an open-label, prospective, single-center phase II clinical trial to evaluate node-sparing short-course radiation (Radiation targeting the tumor bed without irradiating surrounding tumor-draining lymph nodes) combined with total neoadjuvant CAPOX and PD-1 Inhibitor (Sintilimab) for patients with MSS locally advanced of middle and low rectal cancer. A total of 47 patients will be enrolled in this trial. The primary endpoint is the complete response(CR) rate, which includes cCR and pCR. The organ preservation rate, tumor regression grade, 3-year DFS, 3-year OS, and adverse effects will also be analyzed.

Radiation: node-sparing short-course radiotherapy (5Gy\*5d) Drug: PD-1 antibody (Sintilimab) Drug: Capecitabine Drug: Oxaliplatin

Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer

Total Neoadjuvant CAPOX And PD-1 Inhibitor（Sintilimab） Combined With Node-sparing Short-course Radiotherapy For MSS Locally Advanced Of Middle And Low Rectal Cancer(CASINOs): An Open Label, Single-arm, Prospective Clinical Trial

JinhuaCH will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

Pathological complete response (pCR) ：absence of residual tumour on resected specimen. Clinical complete response（cCR）: no residual tumour visible on imaging or colonoscopy and biopsy.

TRG is evaluated according to the AJCC system. TRG0-1 is defined as good response, TRG2 as moderate response, and TRG3 as poor response.

Presence of adenocarcinoma within the rectal wall or within the mesorectum confirmed by pathology.

the time from randomization to recurrence of tumor or death

Rate of radiotherapy, chemotherapy and immunotherapy related adverse events

Rectal specific quality of life according to European Organization for Research and Treatment of Cancer ( EORTC) Quality of life questionnaire QLQ-CR29. scale from 0 to 100, A higher scale represents better function and a higher quality of life.

Quality of life according to EORTC Quality of life Questionnaire QLQ-C30 version 3.0. Score range from 0 to 100 points. A higher score represents better function and a higher quality of life.

The change of severity of fecal incontinence assessment according to Wexner score. a score from 0-20, where 0 is perfect continence and 20 is complete incontinence.

Jinhua Central Hospital

Clinical Professor

Antibodies, Monoclonal

* Short-course radiotherapy (SCRT) + one dose of immunotherapy in week 1：Radiotherapy once daily at 5Gy, D1-D5 (5×5Gy); Penpulimab, 200mg, intravenous for 60±5min, D6 or D7.
* Rest at week 2, 4 cycles of chemotherapy (CAPEOX) + immunotherapy from week 3 in cycles of 3 weeks: Capecitabine, 1000 mg/m2 orally, administered twice daily, D1-D14 per cycle; Oxaliplatin, 135 mg/m2, intravenous \>2h, administered every cycle D1; Penpulimab, 200 mg, administered intravenously for 60 ± 5 min every cycle D1.
* Clinical re-staging assessment at the end of neoadjuvant therapy allows for a watch-and-wait strategy if cCR is achieved. If any residual lesions remained, radical rectal cancer surgery would be performed at least 2 weeks after the last dose of capecitabine. Whether post-operative adjuvant treatment is performed and the option of post-operative adjuvant treatment is decided by the investigator.

Short-course radiotherapy

Apply once in the first week, then every 3 weeks from the third week for four cycles

Penpulimab

Apply every 3 weeks from week 3 for 4 cycles

CAPEOX

Patient will receive radical rectal cancer surgery

Ren Zhao, MD, PHD

The goal of this phase 2 study is to learn about the efficacy and safety of short-course radiotherapy (SCRT) sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable (MSS) locally advanced rectal cancer. The main question it aims to answer is the role of immune checkpoint inhibitors in the neoadjuvant treatment of MSS rectal cancer. Participants will receive neoadjuvant treatment of SCRT sequential Penpulimab in combination with CAPEOX. Participants will undergo a clinical re-staging assessment at the end of neoadjuvant therapy to determine whether to adopt a watch-and-wait strategy or undergo radical surgery.

Today there has been an outbreak progress in immunotherapy for tumors, where immune checkpoint inhibitors targeting PD-1/PD-L1 have been approved for the treatment of a variety of tumors, bringing long-term benefits to some patients, especially colorectal cancer and other solid tumors with dMMR/MSI-H have been identified as the best indication population for immunotherapy. However, the majority of patients presented with microsatellite stable (MSS) or pMMR status had a low response rate to immunotherapy. How to improve the response to immunotherapy in these patients has been a challenge in the field of colorectal cancer immunotherapy. A number of preclinical and small clinical studies have identified immunotherapy in combination with other treatments such as chemotherapy, radiotherapy, anti-angiogenic drugs and targeted therapies as potentially viable options to overcome immune resistance and improve the outcome of MSS colorectal cancer. Preclinical and small clinical studies have demonstrated that radiotherapy may induce antigen release from tumors with low neoantigen load and activate dendritic cells, thereby activating CD8+ T lymphocyte-mediated anti-cancer immune responses. In patients with locally advanced rectal cancer, neoadjuvant chemoradiotherapy can increase PD-L1 expression in tumor cells, suggesting that the combination of radiotherapy and PD-1/PD-L1 inhibitors may have a synergistic effect. To further improve the treatment outcomes of locally advanced rectal cancer, we designed an exploratory observational study to observe the efficacy and safety of a regimen of short-course radiotherapy combined with chemotherapy and the addition of the PD-1 monoclonal antibody in locally advanced rectal cancer, and to initially explore the feasibility a watch-and-wait strategy for patients with rectal cancer who have reached pCR.

This is a two staged, single arm phase II trial of short-course radiotherapy sequential Penpulimab in combination with CAPEOX in the neoadjuvant treatment of microsatellite stable locally advanced rectal cancer. Twenty-three patients will be enrolled in the first phase and if the number of pathological complete remission is ≤ 3, the trial will be terminated; if \> 3, the trial will proceed to the second phase and continue to enroll up to 48 patients. Taking into account a 15% abscission rate, the total number of patients enrolled will be 55.

SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer

Efficacy and Safety of Short-course Radiotherapy Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of Microsatellite Stable Locally Advanced Rectal Cancer: a Single-centre, Single-arm, Phase 2 Study

The proportion of complete remissions detected by postoperative pathological examination (%)

The proportion of complete remissions detected by imaging, endoscopy and digital rectal examination (%)

Sum of proportion in complete and partial remission (%)

3-year disease free survival rate estimated based on Kaplan-Meier method

Histologically complete resection rate (%)

The proportion of low rectal cancer patients retaining the sphincter in radical surgery (%)

Number and severity of adverse events using CTCAE V5.0

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Ruijin Hospital

Chief Physicion

Local CRC with short-course radiotherapy followed by sequential chemotherapy and AK104

Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed).

AK104 injection

This study is a single-arm, open-label, multicenter clinical study to evaluate the efficacy and safety of preoperative short-course radiotherapy combined with AK104 and chemotherapy + TME surgery in patients with advanced rectal cancer.

Studies included a screening period (no more than 28 days after participants signed informed consent form to 28 days before first dose), treatment (receiving appropriate treatment until disease progression, intolerable toxicity, withdrawal of informed consent, death or study end, whichever occurs first), and follow-up (including safety follow-up and survival follow-up).

Eligible subjects will receive short-course radiotherapy (SCRT), IMRT/VMAT, pelvic 25Gy/5f/1 week. Two weeks after the end of treatment, subjects continued to receive neoadjuvant chemotherapy combined with immunotherapy regimen for 4 cycles: AK104 10 mg/kg, intravenous infusion every 3 weeks (Q3W), plus CAPOX (capecitabine: 1000mg/m2, bid, po, d1-14, oxaliplatin: 130mg/m2, ivgtt, d1), Q3W. Neoadjuvant therapy was assessed 2 weeks after the end of neoadjuvant therapy, and TME surgery was performed 4 weeks after the end of neoadjuvant therapy (R0 surgery was performed). Patients are not recommended to enter the organ preservation observation; If the efficacy after preoperative chemoradiotherapy is evaluated as clinical complete remission (cCR) and the patient strongly refuses surgery, the patient should be informed of the risk of recurrence and ask the patient to sign a rejection of surgery. Medication safety is assessed and, depending on the severity of adverse events (AEs) and drug relevance, investigators will take steps to ensure subject safety. After surgery (or patients who strongly refuse surgery) there is a 30- and 90-day safety follow-up, and survival assessments are performed every 3 months to obtain survival information and collect new tumor treatment information until the death of the participant, withdrawal of informed consent, or the end of the study, whichever occurs first.

Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）

A Single-arm, Multicenter, Phase II Study Evaluating the Efficacy and Safety of Preoperative Short-course Radiotherapy Followed by Sequential Chemotherapy and AK104 for Locally Advanced Rectal Cancer

To use PCR to check the immune markers in blood and use immunofluorescent cytochemical techniques to check the immune markers in tumor tissues.The concentration of antigens and antibodies in the blood is measured to determine the efficacy and concentration of the drug after the subject's medication

To assess the result from pathology report

To compute the length between end of treatment and relapse

To compute the length between end of treatment and death

To assess the result from inspection paper during the trail

JIN JING

Chief physician

Symptoms and General Pathology

Anastomotic Leak

Rune Sjödahl, MD, PhD

The hypothesis of the present trial was that the use of a defunctioning loop stoma reduces the rate of symptomatic anastomotic leakage from 15% to 7.5% after low anterior resection of the rectum for cancer.

The assumption that a defunctioning loop stoma reduces symptomatic anastomotic leakage from 15% to 7.5%, with a level of statistical significance of 5% and a statistical power of 80%, requires randomization of 220 patients.

Rectal Cancer Trial On Defunctioning Stoma

Rectal Cancer Trial on Defunctioning Stoma Study Group

Peter Matthiessen, MD, PhD

Micronutrients

Vitamins

Leucovorin

Fluorouracil

Levoleucovorin

Folinic Acid

Short-course radiotherapy and 4 cycles of mFOLFOX6 followed by TME. Adjuvant chemotherapy will be given according to the pathological stage (CR\~pStageI: 6 cycles of capecitabine or 4 cycles of 5-FU with leucovorin, pStageII-III: 8 cycles of mFOLFOX6)

Conventional chemoradiotherapy followed by TME. Adjuvant chemotherapy will be given according to the pathological stage (CR\~pStageI: 6 cycles of capecitabine or 4 cycles of 5-FU with leucovorin, pStageII-III: 8 cycles of mFOLFOX6)

short-course radiotherapy

Oxaliplatin 85 mg/m2, Levoleucovorin 200mg (or Leucovroin, Leucosodium 400mg)/m2, 5- FU 400 mg/m2, and continuous 5- FU 2,400 mg/m2 for 46 hours

mFOLFOX6

45\~50.4 Gy/25fr with concurrent use of either capecitabine or 5-FU+leucovorin(or levoleucovorin or leucosodium)

Chemoradiotherapy

Soo Yeun Park, M.D.

Kyung Ha Lee, M.D.

Chang Hyun Kim, M.D.

Moon Jin Kim, M.D.

Gi Won Ha, M.D.

In Ja Park, M.D.

In Ja Park, MD

Ji-Seon Kim, M.D.

Eun Jung Park, M.D.

Hong-Min Ahn, M.D.

The treatment protocol proposed in this study is to perform short-term radiation therapy and 4 cycles of FOLFOX chemotherapy for neoadjuvant treatment of locally advanced rectal cancer. Compared to conventional chemoradiation therapy, the preoperative radiotherapy period is shortened, and the cure rate of rectal cancer patients can be improved by early treatment of micrometastasis using systemic chemotherapy. The patients who are assigned to the study group will received the short-course radiotherapy and 4 cycles of FOLFOX and patients in the control will received conventional chemoradiotherapy for preoperative treatment. All patients are recommended to receive total mesorectal excision (TME) after neoadjuvant treatment and adjuvant chemotherapy will be given according to the pathological stage.

Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer

A Multicenter, Randomized Controlled Trial of Preoperative Sequential Short-course Radiation Therapy and Oxaliplatin-based Consolidation Chemotherapy for Locally Advanced Rectal Cancer

To compare the 3-year disease-free survival between the experimental arm and the control arm

CR (complete regression), no tumor cells and only fibrotic mass or acellular mucin pools

Neoadjuvant treatment associated toxicity (Common Terminology Criteria for Adverse Events version v5.0)

Pathological tumor regression grade (TRG) (Dworak/Mandard/AJCC TRG classification)

Surgical complications classified according to the Clavien-Dindo classification

Incidence of oxaliplatin-induced peripheral neuopathy

The EORTC Core Questionnaire (QLQ-C30) includes six clearly distinguishable functioning scales that have been thoroughly tested and validated on an international level and that are available in 110 different language versions

The QLQ-CR29 has five functional and 18 symptom scales. It contains four subscales (urinary frequency (UF), blood and mucus in stool (BMS), stool frequency (SF), and body image (BI)) and 19 single items (urinary incontinence, dysuria, abdominal pain, buttock pain, bloating, dry mouth, hair loss, taste, anxiety, weight, flatulence, fecal incontinence, sore skin, embarrassment, stoma care problems, sexual interest (men), impotence, sexual interest (women), and dyspareunia) \[11\]. Patients are asked to indicate their symptoms during the past week(s). Scores can be linearly transformed to provide a score from 0 to 100. Higher scores represent better functioning on the functional scales and a higher level of symptoms on the symptom scales.

Low anterior resection syndrome (LARS) score ; 0 to 20 (no LARS), 21 to 29 (minor LARS ) and 30 to 42 (Major LARS )

Quality of life IIEF-5, retrograde ejaculation

To compare the 5-year disease-free survival between the experimental arm and the control arm

To compare the 3-year overall survival between the experimental arm and the control arm

To compare the 5-year overall survival between the experimental arm and the control arm

To compare the 3 year and 5-year loco-regional recurrence between the experimental arm and the control arm

To compare the 3 year and 5-year distant metastasis between the experimental arm and the control arm

National Cancer Center, Korea

Kyungpook National University Hospital

M.D., Ph.D

Twenty consecutive patients operated on with low anterior resection of the rectum for cancer with a defunctioning stoma who accept participation.

Reversal of defunctioning stoma

Rickard Lindgren, MD

In this trial will be investigated if a defunctioning loop stoma used in low anterior resection of the rectum for cancer can be reversed after 14 days instead of 3-12 months which is present clinical practise.

Patients undergoing low anterior resection of the the rectum for adenocarcinom (total mesorectal excision; TME) with a defunctioning loop stoma are assessed preoperatively and for 6 days postoperatively according to a trial protocol including daily clinical, physiological, and serological variables, and a rectal contrast study on day 6. If inclusion criteria are fulfilled, a decision is taken on day 7 to schedule reversal of the defunctioning loop stoma on postoperative day 14. This trial is considered a hypothesis generating pilot study of feasibility type and is no power calculation. The present trial will include 20 consecutive patients who accept participation.

Analysis of serum C-Reactive Protein (CRP) and Procalcitonin (PCT).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer	NCT02498353	Rectal Cancer	preoperative sh... preoperative sh... TME surgery	18 Years - 70 Years	Zhongnan Hospital
Node-sparing Radiotherapy Combined With Total Neoadjuvant CAPOX and Sintilimab for MSS Middle and Low Rectal Cancer	NCT06204094	Locally Advance...	node-sparing sh... Sintilimab Capecitabine Oxaliplatin TME surgery watch and wait	18 Years - 75 Years	Jinhua Central Hospital
Comparing Preoperative Short-course Radiotherapy With or Without Local Boost for Rectal Cancer	NCT02498353	Rectal Cancer	preoperative sh... preoperative sh... TME surgery	18 Years - 70 Years	Zhongnan Hospital
SCRT Sequential Penpulimab in Combination With CAPEOX in the Neoadjuvant Treatment of MSS Locally Advanced Rectal Cancer	NCT05576480	Rectal Cancer Locally Advance...	Short-course ra... Penpulimab CAPEOX TME surgery	18 Years - 75 Years	Ruijin Hospital
Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）	NCT05794750	Locally Advance...	AK104 injection TME surgery Capecitabine Oxaliplatin	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Rectal Cancer Trial On Defunctioning Stoma	NCT00636948	Rectal Cancer		18 Years -	Rectal Cancer Trial on Defunctioning Stoma Study Group
Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer	NCT05673772	Rectal Cancer	short-course ra... mFOLFOX6 Chemoradiothera... TME surgery	20 Years - 75 Years	Kyungpook National University Hospital
Assess the Efficacy of Radiotherapy and Sequential Chemotherapy and AK104 Before TME Surgery for Local CRC（AK104-IIT-13）	NCT05794750	Locally Advance...	AK104 injection TME surgery Capecitabine Oxaliplatin	18 Years - 75 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Preoperative Sequential Short-course Radiation Therapy and FOLFOX for Locally Advanced Rectal Cancer	NCT05673772	Rectal Cancer	short-course ra... mFOLFOX6 Chemoradiothera... TME surgery	20 Years - 75 Years	Kyungpook National University Hospital
Early Reversal of Defunctioning Stoma Trial	NCT00640913	Rectal Cancer	Reversal of def...	18 Years - 85 Years	Rectal Cancer Trial on Defunctioning Stoma Study Group
Rectal Cancer Trial On Defunctioning Stoma	NCT00636948	Rectal Cancer		18 Years -	Rectal Cancer Trial on Defunctioning Stoma Study Group

Spots Global Cancer Trial Database for tme surgery

Every month we try and update this database with for tme surgery cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for tme surgery

Every month we try and update this database with for tme surgery cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for tme surgery cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.