BridgeMD
New treatment option for Locally Advanced Rectal Cancer
Official title Involved-field Radiotherapy-TNT Combined With PD-1 Inhibitor for pMMR Locally Advanced Rectal Cancer (Neo-Field I)
ClinicalTrials.gov ID: NCT07057089
What this study is testing
What is Capecitabine?
Capecitabine is an investigational medicine, being studied as a potential treatment for locally advanced rectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The purpose of this study is to explore the efficacy and safety of involved-field radiotherapy-TNT combined with PD-1 inhibitors in pMMR locally advanced rectal cancer.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age ≥18 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;
- Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);
- The lower margin of the primary tumor is located below the peritoneal reflex or the lower margin of the tumor is ≤10 cm from the anal verge;
You likely can't join if
- Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc;
- Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer;
- Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy)；
- Presence of active infection (e.g. HIV, HBV/HCV viral load positive requiring stabilization on antiretroviral therapy)；
- Severe cardiovascular disease (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension \>160/100 mmHg)；
- History of other malignant tumors (except non-melanoma skin cancers, cervical cancer in situ, etc. cured for ≥5 years)；
See the full eligibility criteria
- Age ≥18 years old, male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1;
- Pathologic diagnosis of adenocarcinoma of the rectum, definite pMMR type;
- Clinical staging of T3-4NanyM0 or T1-2N+M0 (based on AJCC 8th edition staging criteria);
- The lower margin of the primary tumor is located below the peritoneal reflex or the lower margin of the tumor is ≤10 cm from the anal verge;
- Pre-enrollment laboratory indicators meet the following indicator ranges： 1)Blood: absolute neutrophils ≥1.5×10\^9/L, platelets ≥100×10\^9/L, hemoglobin ≥90g/L; 2)Liver and kidney function: ALT/AST ≤ 2.5 x ULN, total...
- Women or men of childbearing potential need to agree to use effective contraception during the study and for 6 months after the last treatment session;
- Voluntary written informed consent and commitment to complete the full treatment and follow-up program.
- Pathologic type is other specific types such as neuroendocrine carcinoma, squamous carcinoma, etc;
- Previous radiotherapy, chemotherapy, targeted or immunotherapy for rectal cancer;
- Active autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis requiring long-term immunosuppressive therapy)；
- Presence of active infection (e.g. HIV, HBV/HCV viral load positive requiring stabilization on antiretroviral therapy)；
- Severe cardiovascular disease (e.g., myocardial infarction within 6 months, unstable angina, uncontrolled hypertension \>160/100 mmHg)；
- History of other malignant tumors (except non-melanoma skin cancers, cervical cancer in situ, etc. cured for ≥5 years)；
- Uncontrolled diabetes mellitus (HbA1c \> 8%), abnormal thyroid function (TSH outside normal range and requiring pharmacologic intervention)；
- Severe chronic bowel disease (e.g., Crohn's disease, active ulcerative colitis)； Patients deemed by the investigator to be unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Shijiazhuang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shijiazhuang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.