Neoadjuvant TherapyNCT05352165
The Clinical Efficacy of Drug Sensitive Neoadjuvant Chemotherapy Based on Organoid Versus Traditional Neoadjuvant Chemotherapy in Advanced Rectal Cancer
A study testing standard long-term therapy, FOLFOX and standard long-term radiotherapy and FOLFIRI and standard long-term radiotherapy in people with Neoadjuvant Therapy, run by Shanghai Minimally Invasive Surgery Center.
Trial summary
This is a prospective multicenter randomized controlled trial study. According to the enrollment criteria, patients with locally advanced rectal cancer who need neoadjuvant therapy before radical surgery were randomly divided into the organoids drug sensitivity group and the standard whole-course neoadjuvant therapy… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Neoadjuvant Therapy
- What is being tested?
- standard long-term therapy, FOLFOX and standard long-term radiotherapy and FOLFIRI and standard long-term radiotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Age: 18-75. 2) qualitative diagnosis: adenocarcinoma was confirmed by enteroscopic biopsy. 3) Localization diagnosis: the tumor is located in the rectum (the distance between the tumor and the anal margin ≤ 12cm).
- 4) plain scan of thoracoabdominal pelvis and enhanced CT or MRI evaluation of rectal cancer staging:
- The primary tumor invades the muscular layer of the intestinal wall into the surrounding well-known structure, with or without lymph node metastasis in the proper rectal fascia.
- TNM clinical or pathological stage of tumor: T3-T4N0-2M0. 5) physical condition (ECOG) score ≤ 1. 6) all patients agreed to receive adjuvant chemotherapy for 3 to 6 months after operation.
- 7) sign informed consent and participate in the project voluntarily.
Who cannot join
- 1) simultaneous or metachronous multiple primary malignant tumors. 2) preoperative imaging examination or pathological results showed that:
- Lateral lymph node metastasis. b. Distant organ metastasis. 3) previous history of malignant tumors. 4) abnormal function of heart, lung, liver, kidney, hematopoiesis and bone marrow reserve, which can not tolerate neoadjuvant therapy and operation.
- 5) have mental illness or other serious cardiovascular disease. 6) pregnant or lactating women. 7) Emergency surgery (perforation, bleeding, intestinal obstruction, etc.). 8) BRAF mutation was found by gene detection.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Multicenter Randomized Controlled Trial of the Clinical Efficacy of Neoadjuvant Therapy Based on Organoids Drug Sensitivity Versus Empirical Neoadjuvant Therapy in the Treatment of Advanced Rectal Cancer
This is a prospective multicenter randomized controlled trial study. According to the enrollment criteria, patients with locally advanced rectal cancer who need neoadjuvant therapy before radical surgery were randomly divided into the organoids drug sensitivity group and the standard whole-course neoadjuvant therapy group. The Organoids drug sensitivity group was treated with personalized neoadjuvant therapy under the guidance of tumor organoids drug sensitivity technology combined with standard long-term radiotherapy. The standard whole-course neoadjuvant therapy group was treated with neoadjuvant simultaneous radiotherapy and chemotherapy (Total Neoadjuvant Therapy, TNT) based on guidelines and clinical experience. The tumor pathological complete remission rate (pCR), postoperative complication rate, postoperative tumor withdrawal grade, postoperative recurrence rate, treatment tolerance rate, R0 resection rate, and sphincter preservation rate were observed and compared.
Read the detailed description
Based on the need for individualized treatment in the era of precision medicine, an in vitro model that can accurately predict the response of patients to treatment is urgently needed, so that suitable patients can receive effective treatment and patients whose treatments are ineffective can avoid adverse reactions. The emergence of tumor organoids technology makes this vision possible.
Tumor-organoid (Patient-Derived Organoids, PDOs) is a kind of micro-organ with a three-dimensional structure, which is cultivated in the environment of 3D matrix glue in vitro. Based on the individualized neoadjuvant therapy based on the drug sensitivity technology of tumor-organoid, the best neoadjuvant therapy can be selected and the clinical efficacy and drug tolerance can be quickly predicted, which is of great significance in the field of accurate tumor therapy. The preliminary study of our group also completed the organ-like library of more than 100 patients with local advanced rectal cancer. It was proved that the organoids of the organoids library had high homology with the original tumor tissue, and the detection period of drug sensitivity of organoids was less than 2 weeks, which was much less than 2 months of PDX drug sensitivity technology in mice, which did not affect the time window of clinical drug treatment, and the results of drug sensitivity were basically consistent with the clinical efficacy.
Therefore, we have reason to believe that tumor organoids chemosensitivity technology, as an economical, high-throughput, and efficient technology for tumor research, is expected to play an important role in clinical individualized treatment of tumors.
Our previous study found that tumor-based organoids drug sensitivity technology can be used as an effective and reliable clinical assistant tool to guide and assist doctors to formulate the best treatment strategy for tumor patients. Personalized neoadjuvant therapy has better clinical efficacy than standard whole-course neoadjuvant therapy.
Therefore, in this study, through a prospective, multicenter, multi-arm umbrella clinical study, patients with locally advanced rectal cancer who need neoadjuvant therapy are randomly divided into two groups: the organoids drug sensitivity group and the standard whole-course neoadjuvant therapy group. To compare the clinical efficacy of personalized neoadjuvant therapy based on tumor organoids chemosensitivity combined with standard long-term radiotherapy with the clinical efficacy of standard whole-course neoadjuvant therapy in locally advanced rectal cancer. This technology can be used in the clinical use of advanced rectal cancer new auxiliary decision-making system so that the standardization of comprehensive treatment of rectal cancer can be implemented in China, which is of great significance for the development of the national economy and the improvement of medical level in China.
- Conditions
- Neoadjuvant Therapy
- Being tested
- standard long-term therapy, FOLFOX and standard long-term radiotherapy, FOLFIRI and standard long-term radiotherapy, 5-FU and standard long-term radiotherapy, 5-FU and pembrolizumab and standard long-term radiotherapy
- Keywords
- neoadjuvant therapy, organoid drug sensitivity, advanced rectal cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard long-term therapyDrug
The standard whole-course neoadjuvant therapy group was treated with neoadjuvant simultaneous radiotherapy and chemotherapy (Total Neoadjuvant Therapy, TNT) based on guidelines and clinical experience.
FOLFOX and standard long-term radiotherapyDrug
FOLFOX and standard long-term radiotherapy based on organoids drug sensitivity
FOLFIRI and standard long-term radiotherapyDrug
FOLFIRI and standard long-term radiotherapy based on organoids drug sensitivity
5-FU and standard long-term radiotherapyDrug
5-FU and standard long-term radiotherapy based on organoids drug sensitivity
5-FU and pembrolizumab and standard long-term radiotherapyDrug
5-FU and pembrolizumab and standard long-term radiotherapy based on organoids drug sensitivity
Other individualized treatmentsDrug
Other individualized treatments based on organoids drug sensitivity
| Study group | Role | What they receive |
|---|---|---|
| standard long-term therapy | Experimental | The standard whole-course neoadjuvant therapy group was treated with neoadjuvant simultaneous radiotherapy and chemotherapy (Total Neoadjuvant Therapy, TNT) based on guidelines and clinical experience. Receives: Drug: standard long-term therapy; Drug: FOLFOX and standard long-term radiotherapy; Drug: FOLFIRI and standard long-term radiotherapy; Drug: 5-FU and standard long-term radiotherapy; Drug: 5-FU and pembrolizumab and standard long-term radiotherapy; Drug: Other individualized treatments |
| FOLFOX and standard long-term radiotherapy | Active comparator | FOLFOX and standard long-term radiotherapy based on organoids drug sensitivity Receives: Drug: standard long-term therapy; Drug: FOLFOX and standard long-term radiotherapy; Drug: FOLFIRI and standard long-term radiotherapy; Drug: 5-FU and standard long-term radiotherapy; Drug: 5-FU and pembrolizumab and standard long-term radiotherapy; Drug: Other individualized treatments |
| FOLFIRI and standard long-term radiotherapy | Active comparator | FOLFIRI and standard long-term radiotherapy based on organoids drug sensitivity Receives: Drug: standard long-term therapy; Drug: FOLFOX and standard long-term radiotherapy; Drug: FOLFIRI and standard long-term radiotherapy; Drug: 5-FU and standard long-term radiotherapy; Drug: 5-FU and pembrolizumab and standard long-term radiotherapy; Drug: Other individualized treatments |
| 5-FU and standard long-term radiotherapy | Active comparator | 5-FU and standard long-term radiotherapy based on organoids drug sensitivity Receives: Drug: standard long-term therapy; Drug: FOLFOX and standard long-term radiotherapy; Drug: FOLFIRI and standard long-term radiotherapy; Drug: 5-FU and standard long-term radiotherapy; Drug: 5-FU and pembrolizumab and standard long-term radiotherapy; Drug: Other individualized treatments |
| 5-FU and pembrolizumab and standard long-term radiotherapy | Active comparator | 5-FU and pembrolizumab and standard long-term radiotherapy based on organoids drug sensitivity Receives: Drug: standard long-term therapy; Drug: FOLFOX and standard long-term radiotherapy; Drug: FOLFIRI and standard long-term radiotherapy; Drug: 5-FU and standard long-term radiotherapy; Drug: 5-FU and pembrolizumab and standard long-term radiotherapy; Drug: Other individualized treatments |
| Other individualized treatments | Active comparator | Other individualized treatments based on organoids drug sensitivity Receives: Drug: standard long-term therapy; Drug: FOLFOX and standard long-term radiotherapy; Drug: FOLFIRI and standard long-term radiotherapy; Drug: 5-FU and standard long-term radiotherapy; Drug: 5-FU and pembrolizumab and standard long-term radiotherapy; Drug: Other individualized treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathologic Complete Response
Neoadjuvant therapy and postoperative pathology confirmed that the primary tumor was in complete remission (stage ypT0) and had no residual tumor cells, regardless of whether the regional lymph nodes were involved or not.
Measured: 3 years
Secondary outcomes (7)
Postoperative complication
Intra-abdominal bleeding, anastomotic leakage, intra-abdominal infection, intestinal obstruction, postoperative diarrhea, wound infection, pulmonary infection, cardiovascular accident, cerebrovascular accident, etc.
Measured: 3 years
Tumor Regression Grading
Tumor pathological reaction is graded after neoadjuvant therapy, usually according to the proportion of fibrosis and residual tumor in the tumor.
The analytical system for evaluating treatment response recommended by NCCN is as follows: complete response-no living cancer cell residue, moderate reaction-single or small cluster cancer cell residue,mild reaction-residual cancer focus, interstitial fibrosi,adverse reaction-few or no cancer cell regression.
Measured: 3 years
Local recurrence
Recurrence occurs in the surgical area, with or without the rise of tumor markers. The tumor found in the anastomosis needs to be confirmed by pathological biopsy.
Measured: 3 years
Distant metastasis
CT or MRI or radionuclide scan can detect metastases in liver, lung and bone, with or without confirmed by pathology.
Measured: 3 years
Treatment tolerance rate
To evaluate the tolerance and completion of preoperative neoadjuvant therapy.
Measured: 3 years
R0 resection rate
R0 resection rate of laparoscopic radical surgery for rectal cancer after neoadjuvant therapy.
Measured: 3 years
anus-saving rate
anus-saving rate after radical resection of rectal cancer after neoadjuvant therapy
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Neoadjuvant TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective multicenter multi-arm umbrella clinical study.
- Masking
- None (open label)
- Enrolment
- 192 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Minimally Invasive Surgery Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai OneTar Biomedicine Co., Ltd., Ruijin Hospital
- Responsible party
- Sponsor
- Investigators
- Jing Sun, PhD, Principal investigator, Shanghai Minimally Invasive Surgery Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352165
- Sponsor's protocol ID
- MISC-WXXR-001
- Status last verified
- Apr 2022
- First submitted
- 22 Apr 2022
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.
PubMed 33433946Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474.
PubMed 33734139Ludmir EB, Palta M, Willett CG, Czito BG. Total neoadjuvant therapy for rectal cancer: An emerging option. Cancer. 2017 May 1;123(9):1497-1506. doi: 10.1002/cncr.30600. Epub 2017 Mar 10.
PubMed 28295220Garcia-Aguilar J, Chow OS, Smith DD, Marcet JE, Cataldo PA, Varma MG, Kumar AS, Oommen S, Coutsoftides T, Hunt SR, Stamos MJ, Ternent CA, Herzig DO, Fichera A, Polite BN, Dietz DW, Patil S, Avila K; Timing of Rectal Cancer Response to Chemoradiation Consortium. Effect of adding mFOLFOX6 after neoadjuvant chemoradiation in locally advanced rectal cancer: a multicentre, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):957-66. doi: 10.1016/S1470-2045(15)00004-2. Epub 2015 Jul 14.
PubMed 26187751Shamir ER, Ewald AJ. Three-dimensional organotypic culture: experimental models of mammalian biology and disease. Nat Rev Mol Cell Biol. 2014 Oct;15(10):647-64. doi: 10.1038/nrm3873. Epub 2014 Sep 17.
PubMed 25237826Sato T, Vries RG, Snippert HJ, van de Wetering M, Barker N, Stange DE, van Es JH, Abo A, Kujala P, Peters PJ, Clevers H. Single Lgr5 stem cells build crypt-villus structures in vitro without a mesenchymal niche. Nature. 2009 May 14;459(7244):262-5. doi: 10.1038/nature07935. Epub 2009 Mar 29.
PubMed 19329995
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicenter Randomized Controlled Trial of the Clinical Efficacy of Neoadjuvant Therapy Based on Organoids Drug Sensitivity Versus Empirical Neoadjuvant Therapy in the Treatment of Advanced Rectal Cancer
- ClinicalTrials.gov ID
- NCT05352165
- Acronym / sponsor ID
- MISC-WXXR-001
- Conditions
- Neoadjuvant Therapy
- Keywords
- neoadjuvant therapy, organoid drug sensitivity, advanced rectal cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 192 participants (estimated)
- Lead sponsor
- Shanghai Minimally Invasive Surgery CenterUniversity, hospital or other
- Collaborators
- Shanghai OneTar Biomedicine Co., Ltd., Ruijin Hospital
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective multicenter randomized controlled trial study. According to the enrollment criteria, patients with locally advanced rectal cancer who need neoadjuvant therapy before radical surgery were randomly divided into the organoids drug sensitivity group and the standard whole-course neoadjuvant therapy group. The Organoids drug sensitivity group was treated with personalized neoadjuvant therapy under the guidance of tumor organoids drug sensitivity technology combined with standard long-term radiotherapy. The standard whole-course neoadjuvant therapy group was treated with neoadjuvant simultaneous radiotherapy and chemotherapy (Total Neoadjuvant Therapy, TNT) based on guidelines and clinical experience. The tumor pathological complete remission rate (pCR), postoperative complication rate, postoperative tumor withdrawal grade, postoperative recurrence rate, treatment tolerance rate, R0 resection rate, and sphincter preservation rate were observed and compared.
Detailed description
Based on the need for individualized treatment in the era of precision medicine, an in vitro model that can accurately predict the response of patients to treatment is urgently needed, so that suitable patients can receive effective treatment and patients whose treatments are ineffective can avoid adverse reactions. The emergence of tumor organoids technology makes this vision possible.
Tumor-organoid (Patient-Derived Organoids, PDOs) is a kind of micro-organ with a three-dimensional structure, which is cultivated in the environment of 3D matrix glue in vitro. Based on the individualized neoadjuvant therapy based on the drug sensitivity technology of tumor-organoid, the best neoadjuvant therapy can be selected and the clinical efficacy and drug tolerance can be quickly predicted, which is of great significance in the field of accurate tumor therapy. The preliminary study of our group also completed the organ-like library of more than 100 patients with local advanced rectal cancer. It was proved that the organoids of the organoids library had high homology with the original tumor tissue, and the detection period of drug sensitivity of organoids was less than 2 weeks, which was much less than 2 months of PDX drug sensitivity technology in mice, which did not affect the time window of clinical drug treatment, and the results of drug sensitivity were basically consistent with the clinical efficacy.
Therefore, we have reason to believe that tumor organoids chemosensitivity technology, as an economical, high-throughput, and efficient technology for tumor research, is expected to play an important role in clinical individualized treatment of tumors.
Our previous study found that tumor-based organoids drug sensitivity technology can be used as an effective and reliable clinical assistant tool to guide and assist doctors to formulate the best treatment strategy for tumor patients. Personalized neoadjuvant therapy has better clinical efficacy than standard whole-course neoadjuvant therapy.
Therefore, in this study, through a prospective, multicenter, multi-arm umbrella clinical study, patients with locally advanced rectal cancer who need neoadjuvant therapy are randomly divided into two groups: the organoids drug sensitivity group and the standard whole-course neoadjuvant therapy group. To compare the clinical efficacy of personalized neoadjuvant therapy based on tumor organoids chemosensitivity combined with standard long-term radiotherapy with the clinical efficacy of standard whole-course neoadjuvant therapy in locally advanced rectal cancer. This technology can be used in the clinical use of advanced rectal cancer new auxiliary decision-making system so that the standardization of comprehensive treatment of rectal cancer can be implemented in China, which is of great significance for the development of the national economy and the improvement of medical level in China.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
- Model description
- This is a prospective multicenter multi-arm umbrella clinical study.
| Arm | Type | Receives |
|---|---|---|
| standard long-term therapy | Experimental | Drug: standard long-term therapy, Drug: FOLFOX and standard long-term radiotherapy, Drug: FOLFIRI and standard long-term radiotherapy, Drug: 5-FU and standard long-term radiotherapy, Drug: 5-FU and pembrolizumab and standard long-term radiotherapy, Drug: Other individualized treatmentsThe standard whole-course neoadjuvant therapy group was treated with neoadjuvant simultaneous radiotherapy and chemotherapy (Total Neoadjuvant Therapy, TNT) based on guidelines and clinical experience. |
| FOLFOX and standard long-term radiotherapy | Active comparator | Drug: standard long-term therapy, Drug: FOLFOX and standard long-term radiotherapy, Drug: FOLFIRI and standard long-term radiotherapy, Drug: 5-FU and standard long-term radiotherapy, Drug: 5-FU and pembrolizumab and standard long-term radiotherapy, Drug: Other individualized treatmentsFOLFOX and standard long-term radiotherapy based on organoids drug sensitivity |
| FOLFIRI and standard long-term radiotherapy | Active comparator | Drug: standard long-term therapy, Drug: FOLFOX and standard long-term radiotherapy, Drug: FOLFIRI and standard long-term radiotherapy, Drug: 5-FU and standard long-term radiotherapy, Drug: 5-FU and pembrolizumab and standard long-term radiotherapy, Drug: Other individualized treatmentsFOLFIRI and standard long-term radiotherapy based on organoids drug sensitivity |
| 5-FU and standard long-term radiotherapy | Active comparator | Drug: standard long-term therapy, Drug: FOLFOX and standard long-term radiotherapy, Drug: FOLFIRI and standard long-term radiotherapy, Drug: 5-FU and standard long-term radiotherapy, Drug: 5-FU and pembrolizumab and standard long-term radiotherapy, Drug: Other individualized treatments5-FU and standard long-term radiotherapy based on organoids drug sensitivity |
| 5-FU and pembrolizumab and standard long-term radiotherapy | Active comparator | Drug: standard long-term therapy, Drug: FOLFOX and standard long-term radiotherapy, Drug: FOLFIRI and standard long-term radiotherapy, Drug: 5-FU and standard long-term radiotherapy, Drug: 5-FU and pembrolizumab and standard long-term radiotherapy, Drug: Other individualized treatments5-FU and pembrolizumab and standard long-term radiotherapy based on organoids drug sensitivity |
| Other individualized treatments | Active comparator | Drug: standard long-term therapy, Drug: FOLFOX and standard long-term radiotherapy, Drug: FOLFIRI and standard long-term radiotherapy, Drug: 5-FU and standard long-term radiotherapy, Drug: 5-FU and pembrolizumab and standard long-term radiotherapy, Drug: Other individualized treatmentsOther individualized treatments based on organoids drug sensitivity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1) Age: 18-75. 2) qualitative diagnosis: adenocarcinoma was confirmed by enteroscopic biopsy. 3) Localization diagnosis: the tumor is located in the rectum (the distance between the tumor and the anal margin ≤ 12cm).
- 4) plain scan of thoracoabdominal pelvis and enhanced CT or MRI evaluation of rectal cancer staging:
- The primary tumor invades the muscular layer of the intestinal wall into the surrounding well-known structure, with or without lymph node metastasis in the proper rectal fascia.
- TNM clinical or pathological stage of tumor: T3-T4N0-2M0. 5) physical condition (ECOG) score ≤ 1. 6) all patients agreed to receive adjuvant chemotherapy for 3 to 6 months after operation.
- 7) sign informed consent and participate in the project voluntarily.
Key exclusion criteria (3 listed)
- 1) simultaneous or metachronous multiple primary malignant tumors. 2) preoperative imaging examination or pathological results showed that:
- Lateral lymph node metastasis. b. Distant organ metastasis. 3) previous history of malignant tumors. 4) abnormal function of heart, lung, liver, kidney, hematopoiesis and bone marrow reserve, which can not tolerate neoadjuvant therapy and operation.
- 5) have mental illness or other serious cardiovascular disease. 6) pregnant or lactating women. 7) Emergency surgery (perforation, bleeding, intestinal obstruction, etc.). 8) BRAF mutation was found by gene detection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard long-term therapyThe standard whole-course neoadjuvant therapy group was treated with neoadjuvant simultaneous radiotherapy and chemotherapy (Total Neoadjuvant Therapy, TNT) based on guidelines and clinical experience. | Drug | 5-FU and pembrolizumab and standard long-term radiotherapy, 5-FU and standard long-term radiotherapy, FOLFIRI and standard long-term radiotherapy, FOLFOX and standard long-term radiotherapy, Other individualized treatments, standard long-term therapy |
| FOLFOX and standard long-term radiotherapyFOLFOX and standard long-term radiotherapy based on organoids drug sensitivity | Drug | 5-FU and pembrolizumab and standard long-term radiotherapy, 5-FU and standard long-term radiotherapy, FOLFIRI and standard long-term radiotherapy, FOLFOX and standard long-term radiotherapy, Other individualized treatments, standard long-term therapy |
| FOLFIRI and standard long-term radiotherapyFOLFIRI and standard long-term radiotherapy based on organoids drug sensitivity | Drug | 5-FU and pembrolizumab and standard long-term radiotherapy, 5-FU and standard long-term radiotherapy, FOLFIRI and standard long-term radiotherapy, FOLFOX and standard long-term radiotherapy, Other individualized treatments, standard long-term therapy |
| 5-FU and standard long-term radiotherapy5-FU and standard long-term radiotherapy based on organoids drug sensitivity | Drug | 5-FU and pembrolizumab and standard long-term radiotherapy, 5-FU and standard long-term radiotherapy, FOLFIRI and standard long-term radiotherapy, FOLFOX and standard long-term radiotherapy, Other individualized treatments, standard long-term therapy |
| 5-FU and pembrolizumab and standard long-term radiotherapy5-FU and pembrolizumab and standard long-term radiotherapy based on organoids drug sensitivity | Drug | 5-FU and pembrolizumab and standard long-term radiotherapy, 5-FU and standard long-term radiotherapy, FOLFIRI and standard long-term radiotherapy, FOLFOX and standard long-term radiotherapy, Other individualized treatments, standard long-term therapy |
| Other individualized treatmentsOther individualized treatments based on organoids drug sensitivity | Drug | 5-FU and pembrolizumab and standard long-term radiotherapy, 5-FU and standard long-term radiotherapy, FOLFIRI and standard long-term radiotherapy, FOLFOX and standard long-term radiotherapy, Other individualized treatments, standard long-term therapy |
Primary outcome
Pathologic Complete Response
Time frame: 3 years
Neoadjuvant therapy and postoperative pathology confirmed that the primary tumor was in complete remission (stage ypT0) and had no residual tumor cells, regardless of whether the regional lymph nodes were involved or not.
7 secondary outcomes
Postoperative complication
Time frame: 3 years
Tumor Regression Grading
Time frame: 3 years
Local recurrence
Time frame: 3 years
Distant metastasis
Time frame: 3 years
Treatment tolerance rate
Time frame: 3 years
R0 resection rate
Time frame: 3 years
anus-saving rate
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
- Background: PubMed 33433946Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer Statistics, 2021. CA Cancer J Clin. 2021 Jan;71(1):7-33. doi: 10.3322/caac.21654. Epub 2021 Jan 12.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 33734139Cao W, Chen HD, Yu YW, Li N, Chen WQ. Changing profiles of cancer burden worldwide and in China: a secondary analysis of the global cancer statistics 2020. Chin Med J (Engl). 2021 Mar 17;134(7):783-791. doi: 10.1097/CM9.0000000000001474.
- Background: PubMed 28295220Ludmir EB, Palta M, Willett CG, Czito BG. Total neoadjuvant therapy for rectal cancer: An emerging option. Cancer. 2017 May 1;123(9):1497-1506. doi: 10.1002/cncr.30600. Epub 2017 Mar 10.
- Background: PubMed 26187751Garcia-Aguilar J, Chow OS, Smith DD, Marcet JE, Cataldo PA, Varma MG, Kumar AS, Oommen S, Coutsoftides T, Hunt SR, Stamos MJ, Ternent CA, Herzig DO, Fichera A, Polite BN, Dietz DW, Patil S, Avila K; Timing of Rectal Cancer Response to Chemoradiation Consortium. Effect of adding mFOLFOX6 after neoadjuvant chemoradiation in locally advanced rectal cancer: a multicentre, phase 2 trial. Lancet Oncol. 2015 Aug;16(8):957-66. doi: 10.1016/S1470-2045(15)00004-2. Epub 2015 Jul 14.
- Background: PubMed 25237826Shamir ER, Ewald AJ. Three-dimensional organotypic culture: experimental models of mammalian biology and disease. Nat Rev Mol Cell Biol. 2014 Oct;15(10):647-64. doi: 10.1038/nrm3873. Epub 2014 Sep 17.
- Background: PubMed 19329995Sato T, Vries RG, Snippert HJ, van de Wetering M, Barker N, Stange DE, van Es JH, Abo A, Kujala P, Peters PJ, Clevers H. Single Lgr5 stem cells build crypt-villus structures in vitro without a mesenchymal niche. Nature. 2009 May 14;459(7244):262-5. doi: 10.1038/nature07935. Epub 2009 Mar 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Sun, PhD principal investigator
Shanghai Minimally Invasive Surgery Center
Questions about this trial
What is this clinical trial studying?
A study testing standard long-term therapy, FOLFOX and standard long-term radiotherapy and FOLFIRI and standard long-term radiotherapy in people with Neoadjuvant Therapy, run by Shanghai Minimally Invasive Surgery Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Sun, PhD (+86-21-64370045, sj11788@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathologic Complete Response (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05352165, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2022.