Neoplasms

Digestive System Diseases

All Conditions

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

All Drugs and Chemicals

Antineoplastic Agents

Antibodies

Capecitabine

Oxaliplatin

Immunoglobulins

Immunologic Factors

Antimetabolites

Induction regimen: Capeox+PD1 antibody for 1 cycle, Concurrent chemoradiotherapy regimen: Capeox+PD1 antibody for 2 cycles and concurrent , Interval regimen: Capeox+PD1 antibody for 1 cycle, TME surgery or watch and wait for cCR patients Adjuvant regimen: Capeox+PD1 antibody for 2 cycles, Capecitabine+PD1 antibody for 2 cycles

PD-1 antibody 240mg,I.V,D1,repeat every 3 weeks, Four cycles in the neoadjuvant treatment, and four cycles in the adjuvant treatment,

PD-1 Antibody

Oxiliplatin 130mg/m\^2 (100mg/m\^2 during radiotherapy),I.V,D1,repeat every 3 weeks, Four cycles in the neoadjuvant treatment in Capeox regimen, and two cycles in the adjuvant treatment in Capeox regimen

Capecitabine 1000mg/m\^2,Bid,P.O,D1-D14,repeat every 3 weeks, Four cycles in the neoadjuvant treatment in Capeox regimen, and two cycles in the adjuvant treatment in Capeox regimen, and two cycles in adjuvant treatment in Capecitabine regimen

Neoadjuvant radiotherapy, 50Gy/25Fractions to the GTV, 45Gy/25Fractions to the CTV

External beam radiotherapy

Total mesorectal excision

PD1 antibody is now recommended for dMMR/MSI-H metastatic colorectal cancer patients as second line. Chemoradiotherapy is standand treatment for locally advanced rectal cancer and is also recommended as an alternative choice for unresectable locally advanced colon cancer. Thus, this study will investigate the efficacy and toxicity of combination strategy using PD1 antibody and chemoradiotherapy for dMMR/MSI-H locally advnaced colorectal cancer patients.

PD1 antibody is recommended for dMMR/MSI-H metastatic colorectal cancer patients as second line. Chemoradiotherapy is standand treatment for locally advanced rectal cancer and is also recommended as an alternative choice for unresectable locally advanced colon cancer. Thus, this phase II, single arm study will investigate the efficacy and toxicity of combination strategy using PD1 antibody and chemoradiotherapy for dMMR/MSI-H locally advnaced colorectal cancer patients, which is expected to yield higher tumor regressiona with tolerable toxicity.

PD1 Antibody Toripalimab and Chemoradiotherapy for dMMR/MSI-H Locally Advanced Colorectal Cancer

According to pathological response to assess the efficiency of treatment

Sun Yat-sen University

Professor

Micronutrients

Herbal and Botanical

Bevacizumab

Leucovorin

Fluorouracil

Cola

Advanced Colorectal Cancer with planned treatment with a aCRC or mCRC and who fulfil all inclusion and exclusion criteria

Biomarker analysis

Primary Objective:

The primary objective is to validate previously identified predictive/prognostic genomic DNA and expression biomarkers of response to combination bvz treatments in K-ras mutant advanced CRC (a CRC) or metastatic CRC (mCRC).

Secondary Objective:

1. To test the efficacy of bvz in combination with FOLFOX in patients with newly diagnosed advanced or metastatic K-ras mutant CRC and
2. To determine the progression free and overall survival of patients under first line FOLFOX + bvz in aCRC or mCRC.

Study Design:

Type of Study: Exploratory, translational, multicenter and multinational Phase II study.

Patient Population:All patients from the intent-to-treat population with aCRC or mCRC, (incurable with any conventional multimodality approach) and who fulfil all inclusion and exclusion criteria.

Number of Patients: 224

Sample Type:

Serial tissue and blood samples will be collected before (week 0), during (week 6, month 3 and 6) and at the end of treatment (month 12).

ANGIOPREDICT. ICORG 12-16, V3

Exploratory Phase II Clinical Trial Comprising Biomarker Analysis of Oxaliplatin Plus Fluorouracil/Leucovorin (FOLFOX) in Combination With Bevacizumab (Bvz) in First Line Treatment of Metastatic Colorectal Cancer (CRC) Expressing Mutant K-ras - AC-ANGIOPREDICT

Identification of biomarkers, which are predictive for response and/or prolonged PFS to FOLFOX/bvz combination therapy in aCRC or mCRC patients.

Validation of identified biomarkers with regard to response rate/failure to further treatment strategy, PFS, overall survival (OS) and toxicity.

Cancer Trials Ireland

Pembrolizumab

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Immune Checkpoint Inhibitors

CapOx: Capecitabine is given orally at 1500mg / m² twice a day from day1-14 every 3 weeks for 4 cycles and Oxaliplatin is given by intravenous infusion at 200mg / m2 on Day 1 every 3 weeks for 4 cycles;

Bevacizumab：Bevacizumab is given intravenously at 10mg/kg on day 1 every 3 weeks for 4 cycles;

Pembrolizumab：Pembrolizumab is given intravenously at 200 mg on day 1 every 3 weeks for 4 cycles

Capecitabine is given orally at 1500mg / m² twice a day from day1-14 every 3weeks for 3 cycles

Oxaliplatin is given by intravenous infusion at 200mg / m2 on Day 1 every 3 weeks for 3cycles

Bevacizumab is given intravenously at 10mg/kg on day 1 every 3 weeks for 3 cycles

Pembrolizumab is given intravenously at 200 mg on day 1 every 3 weeks for 3 cycles

Haiyang Zhou, MD

This prospective, single-arm study aims to investigate the safety and efficacy of pembrolizumab plus bevacizumab and chemotherapy as neoadjuvant treatment in pMMR/MSS locally advanced colorectal cancer patients

Preoperative Pembrolizumab Plus Bevacizumab Combined With Chemotherapy in Patients With pMMR/MSS Locally Advanced Colorectal Cancer

Safety and Efficacy of Pembrolizumab Combined With CAPOX Plus Bevacizumab as Neoadjuvant Treatment of pMMR/MSS Locally Advanced Colorectal Cancer Patients：a Single-arm, Phase II, Prospective Study

Percentage of patients who achieve R0 resection

Percentage of patients who achieve pathological complete response (pCR) based on local investigator

Percentage of patients who achieve partial response (PR) or complete response (CR) based on Response Evaluation Criteria In Solid Tumors (RECIST)

Measure of time from study treatment to disease progression or death

Measure of time from the date of surgery to disease relapse or death

Percentage of patients who achieve disease-free survival lasting for more than one and two years respectively from the date of surgery

Percentage of patients who achieve survival for more than one and two years respectively from date of first dose

Assessment of life quality based on EORTC QLQ-C30

Shanghai Changzheng Hospital

Symptoms and General Pathology

Wounds and Injuries

Behaviors and Mental Disorders

Hyperthermia

Fever

Body Temperature Changes

Stress Disorders, Traumatic

Heat Stress Disorders

Bone Density Conservation Agents

Hematinics

Vitamins

Levoleucovorin

Raltitrexed

Calcium

Calcium, Dietary

Hormones

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folic Acid Antagonists

Enzyme Inhibitors

Folinic Acid

Folate

Vitamin B9

Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months.

Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. Patients also undergo HIPEC with raltitrexed (3mg/m2) intraperitoneally for 60 minutes during surgery or within 10 days after the operation.

Patients undergo radical resection of colorectal cancer (open/laparoscopic) and receive standard adjuvant systemic chemotherapy comprising mFOLFOX6/CapeOx/sLV5FU2/Cape. Systemic chemotherapy will continue for 6 months. Patients also undergo HIPEC comprising oxaliplatin (130mg/m2) intraperitoneally during surgery and hyperthermia for 30 minutes, following leucovorin calcium (20mg/m2 intravenously) and 5-FU (400 mg/m2 intravenously)

Patients undergo radical surgery with standard adjuvant systemic chemotherapy (mFOLFOX6/CapeOx/sLV5FU2/Cape).

mFOLFOX6: oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.

CapeOx: oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.

sLV5FU2: leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.

Cape: capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.

Standard adjuvant systemic chemotherapy

Raltitrexed (3 mg/m2) is added to the perfusate after attaining 42 degrees of inflow temperature and last for 60 minutes.

Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed

Before the beginning of HIPEC, 5-FU 400 mg/m2 and leucovorin calcium 20 mg/m2 will be administered intravenously to potentiate oxaliplatin activity. Oxaliplatin (130 mg/m2) is added to the perfusate after attaining 42 degrees inflow temperature with a total of 30 minutes perfusion time.

Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin

Guoxiang Cai, M.D. Ph.D.

This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer

Peritoneum is one of the common sites of metastasis in advanced stage colorectal cancer patients, resulting in a poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is effective to colorectal peritoneal metastasis and may play a significant role in reducing the risk of metachronous peritoneal metastasis among patients with locally advanced colorectal cancer. Oxaliplatin is routinely used for HIPEC in the Europe and Raltitrexed may be another ideal drug for HIPEC. The present phase II multicenter, randomized controlled trial is designed to evaluate the efficacy and safety of adjuvant HIPEC with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer.

Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)

Multicenter, Randomized Controlled Trial Designed to Evaluate the Efficacy and Safety of Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) With Raltitrexed or Oxaliplatin Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)

Fudan University

Associate Professor

Irinotecan

Topoisomerase I Inhibitors

Patients will receive a modified FOLFOXIRI regimen (nanoliposomal irinotecan 60mg/m2, oxaliplatin 85 mg/m2, and capecitabine 800 mg/m2 twice daily, day 1 to 7), repeated every two weeks. The efficacy and resectability were evaluated every four cycles. Patients who had lesions that were radically resectable after evaluation will receive surgery. This medication will be administrated until disease progression or unacceptable toxicity or resectability or up to a maximum of 12 cycles.

Nanoliposomal irinotecan 60mg/m2; Oxaliplatin 85 mg/m2; Capecitabine 800 mg/m2 twice daily, day 1 to 7; repeated every two weeks.

Nanoliposomal Irinotecan, Oxaliplatin plus Capecitabine

Lin Yang

Neoadjuvant chemotherapy has gained acceptance in treating locally advanced breast cancer, esophageal cancer, gastric cancer, and rectal cancer. However, the role of neoadjuvant chemotherapy for locally advanced colon cancer is still in the exploratory stage. The objective of this study is to explore the efficacy and safety of nanoliposomal irinotecan and oxaliplatin combined with capecitabine as a novel conversion therapy for locally advanced colorectal cancer patients.

After patients are enrolled, they will receive a modified FOLFOXIRI regimen (nanoliposomal irinotecan 60mg/m2, oxaliplatin 85 mg/m2, and capecitabine 800 mg/m2 twice daily, day 1 to 7), repeated every two weeks. The efficacy and resectability were evaluated every four cycles. Patients who had lesions that were radically resectable after evaluation will receive surgery. This medication will be administrated until disease progression or unacceptable toxicity or resectability or up to a maximum of 12 cycles.

Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine as Conversion Therapy of Locally Advanced Colorectal Cancer

Phase II Study of Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine as Conversion Therapy for Patients With Locally Advanced Colorectal Cancer

The proportion of patients achieved R0 resection by only resecting the colon while other organs were retained.

Tumor regression grade evaluated by pathologists

The proportion of patients who experienced residual or recurrent disease within 2 years after surgery.

The proportion of patients achieved 3-year survival from treatment.

The proportion of patients did not progress at least 3 years from treatment.

Incidence of Treatment-Related Adverse Events

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PD1 Antibody Toripalimab and Chemoradiotherapy for dMMR/MSI-H Locally Advanced Colorectal Cancer	NCT04301557	DMMR Colorectal... MSI-H Colorecta... Locally Advance...	PD-1 Antibody Oxaliplatin Capecitabine External beam r... Total mesorecta...	18 Years - 72 Years	Sun Yat-sen University
ANGIOPREDICT. ICORG 12-16, V3	NCT01822444	Advanced Colore...	Biomarker analy...	18 Years -	Cancer Trials Ireland
Preoperative Pembrolizumab Plus Bevacizumab Combined With Chemotherapy in Patients With pMMR/MSS Locally Advanced Colorectal Cancer	NCT05585814	Locally Advance...	Capecitabine Oxaliplatin Bevacizumab Pembrolizumab	18 Years - 75 Years	Shanghai Changzheng Hospital
Preoperative Pembrolizumab Plus Bevacizumab Combined With Chemotherapy in Patients With pMMR/MSS Locally Advanced Colorectal Cancer	NCT05585814	Locally Advance...	Capecitabine Oxaliplatin Bevacizumab Pembrolizumab	18 Years - 75 Years	Shanghai Changzheng Hospital
ANGIOPREDICT. ICORG 12-16, V3	NCT01822444	Advanced Colore...	Biomarker analy...	18 Years -	Cancer Trials Ireland
Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)	NCT02965248	Locally Advance...	Standard adjuva... Hyperthermic in... Hyperthermic in...	18 Years - 75 Years	Fudan University
ANGIOPREDICT. ICORG 12-16, V3	NCT01822444	Advanced Colore...	Biomarker analy...	18 Years -	Cancer Trials Ireland
Nanoliposomal Irinotecan, Oxaliplatin Plus Capecitabine as Conversion Therapy of Locally Advanced Colorectal Cancer	NCT06405139	Colorectal Canc...	Nanoliposomal I...	18 Years - 70 Years	Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Spots Global Cancer Trial Database for locally advanced colorectal cancer