NCT05914389RecruitingPhase 2
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer
Induction Chemotherapy Combined With Neoadjuvant Immunotherapy for MSS Colon Cancer: a Prospective Single-center Multi-arm Open-label Randomized Phase II Study
Source: ClinicalTrials.gov · Last updated 8 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This study aims to elucidate the regression effects of neoadjuvant chemotherapy combined with immunotherapy and adjuvant therapy in locally advanced MSS colon cancer.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 28 May 2023
- Start date
- Aug 2023
- Primary completion date
- Aug 2025
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Colorectal cancer
- NCT number
- NCT05914389
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From Aug 2023 to the primary completion date, Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cannot tolerate chemotherapy, such as but not limited to bone marrow suppression.
- Peripheral sensory neuropathy, unable to receive oxaliplatin-based chemotherapy.
- Unable to undergo enhanced CT examination or having comorbidities requiring the use of glucocorticoid therapy.
- Continuous use of glucocorticoids for more than 3 days within 1 month prior to signing the informed consent form.
Other illness
- Multifocal colorectal cancer.
- History of malignant tumors, except for basal cell carcinoma, papillary thyroid carcinoma, and various in situ cancers.
- Acute exacerbation of important organ diseases (such as but not limited to COPD, coronary heart disease, and renal insufficiency) and/or severe acute infectious diseases (such as but not limited to hepatitis, pneumonia, and myocarditis), ASA score \> 3 points.
- Mental disorders, illiteracy, or language communication barriers that prevent the understanding of the study protocol.
- Tumor obstruction or high risk of obstruction, bleeding, and/or perforation.
Other
- Refused to participate in this study.
- Pregnancy or lactation.
- CT or MRI in the mid-sagittal plane shows that the lower border of the tumor is below the line connecting the sacrococcygeal promontory and the upper border of the pubic symphysis.
- Other situations in which the researcher deems unsuitable for this study.
Who the study is looking for
- Age ≥18 years old and ≤75 years old.
- Pathologically diagnosed MSS or pMMR-type colon adenocarcinoma.
- The lower edge of the tumor is more than 12cm from the anus as measured by colonoscopy and the lower edge of the tumor cannot be directly palpated during rectal examination.
- Enhanced CT stage T3/4 or T1-4N+ without multiple primary tumors or distant metastasis.
- Life expectancy is expected to be more than 1 year.
- First diagnosis, no previous anti-tumor treatment received, and no chemotherapy contraindications.
- Informed consent, able to understand the study protocol and willing to participate in the study, and will provide written informed consent.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital of Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.