Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer
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| ClinicalTrials.gov Identifier: NCT05086627 |
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Recruitment Status :
Recruiting
First Posted : October 21, 2021
Last Update Posted : October 21, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Locally Advanced Rectal Cancer | Drug: Tislelizumab Radiation: Short-course radiotherapy Drug: Capecitabine+Oxaliplatin | Phase 2 |
Subjects in group A will be treated according to the following treatment plan:
Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 5 days following completion of SCRT, patients were treated with Tislelizumab (days 11, 33, 55, 77) and neoadjuvant chemotherapy with CapeOX (days 11 to 25, 33 to 47, 55 to 69, and 77 to 91).
Surgery: Total mesorectal excision will be performed between day 98 and 105, i.e., between 1 to 2 weeks after completion of Sequential treatment) Postoperative adjuvant chemotherapy: Chemotherapy will be started 4-6 weeks after surgery, and the adjuvant regimen was CapeOX for 2 cycles.
Subjects in group B will be treated according to the following treatment plan:
Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 5 days following completion of SCRT, patients were treated with neoadjuvant chemotherapy with CapeOX (days 11 to 25, 33 to 47, 55 to 69, and 77 to 91).
Surgery: Total mesorectal excision will be performed between day 98 and 105, i.e., between 1 to 2 weeks after completion of Sequential treatment.
Postoperative adjuvant chemotherapy: Chemotherapy will be started 4-6 weeks after surgery, and the adjuvant regimen was CapeOX for 2 cycles.
The Primary endpoint of the study is Pathological complete response rate(PCR ) assessed by the blind independent review committee (BIRC), defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Single -Centers, Randomized, Open-label, Controlled Phase Ⅱ Clinical Trial of Short-course Radiotherapy Followed by Tislelizumab + CapeOX in the Treatment for Locally Advanced Rectal Cancer |
| Estimated Study Start Date : | October 15, 2021 |
| Estimated Primary Completion Date : | May 15, 2024 |
| Estimated Study Completion Date : | May 15, 2026 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Short-course radiotherapy sequential Tislelizumab combined with CapeOX (group A)
Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 5 days following completion of SCRT, patients were treated with Tislelizumab (days 11, 33, 55, 77) and neoadjuvant chemotherapy with CapeOX (days 11 to 25, 33 to 47, 55 to 69, and 77 to 91). Surgery: Total mesorectal excision will be performed between day 98 and 105, i.e., between 1 to 2 weeks after completion of Sequential treatment) Postoperative adjuvant chemotherapy: Chemotherapy will be started 4-6 weeks after surgery, and the adjuvant regimen was CapeOX for 2 cycles. |
Drug: Tislelizumab
Patients were treated with Tislelizumab (days 11, 33, 55, 77) Radiation: Short-course radiotherapy Patients were treated with short-course neoadjuvant radiotherapy Drug: Capecitabine+Oxaliplatin Patients were treated with neoadjuvant chemoherapy with CapeOX |
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Active Comparator: Short-course radiotherapy sequential CapeOX (group B)
Standard SCRT: A total radiation dose of 25 Gy was delivered in 5 fractions (from day 1 to 5) Sequential treatment period: After resting for 5 days following completion of SCRT, patients were treated with neoadjuvant chemotherapy with CapeOX (days 11 to 25, 33 to 47, 55 to 69, and 77 to 91). Surgery: Total mesorectal excision will be performed between day 98 and 105, i.e., between 1 to 2 weeks after completion of Sequential treatment. Postoperative adjuvant chemotherapy: Chemotherapy will be started 4-6 weeks after surgery, and the adjuvant regimen was CapeOX for 2 cycles. |
Radiation: Short-course radiotherapy
Patients were treated with short-course neoadjuvant radiotherapy Drug: Capecitabine+Oxaliplatin Patients were treated with neoadjuvant chemoherapy with CapeOX |
- Pathological complete response rate [ Time Frame: A week after surgery ]Pathological complete response rate was defined as the absence of viable tumour cells in the resected primary tumour specimen and all sampled regional lymph nodes (ypT0N0)
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients or their family members agree to participate in the study and sign the informed consent form;
Patients ≥ 18 and ≤75 years old, male or female;
ECOG performance status of 0 or 1;
Patients with histologically confirmed rectal adenocarcinoma;
The clinical diagnosis of chest CT, abdomen and enhanced MRI was cT3/T4a, Nany, M0;
The distance between the lower edge of the tumor and the anal edge is less than or equal to 10 cm;
No history of immune system diseases;
No history of immunodeficiency, including HIV positive;
No history of other malignancies;
No history of myocarditis;
No history of cardiovascular and cerebrovascular diseases;
No history of thyroid dysfunction;
No history of liver and kidney diseases;
No history of mental illness, no history of Infectious diseases;
No history of organ transplantation or allogeneic bone marrow transplantation;
There is no history of other systemic diseases other than the above diseases;
Voluntarily accept the neoadjuvant treatment scheme of radiotherapy, sequential chemotherapy / chemotherapy combined with immunotherapy;
Swallowing pills normally;
Rectal cancer without radiotherapy, chemotherapy, surgery, Chinese medicine anti-tumor treatment, etc.;
Surgical treatment is planned after neoadjuvant treatment.
Exclusion Criteria:
Patients who do not meet the above inclusion criteria;
Documented history of allergy to study drugs, including any component of Tislelizumab, capecitabine, oxaliplatin and other platinum drugs;
Patients who need to be treated with corticosteroid (dose equivalent to prednisone of >10 mg/day) or other immunosuppressive agents within 2 weeks prior to study drug administration; Major surgery or severe trauma within 4 weeks before the first use of the study drug;
Severe infection (CTCAE > 2) occurred within 4 weeks before the first use of the study drug; Baseline chest imaging revealed active pulmonary inflammation, signs and symptoms of infection within 14 days prior to the first use of the study drug, or oral or intravenous antibiotic therapy, except for prophylactic use of antibiotics;
Female patients who is pregnant or breastfeeding;
Patients who refuse to sign informed consent by themselves or their authorized persons;
Patients with poor cognitive ability, unable to answer questions, unable to fill in questionnaires or mental disorders;
Patients considered unsuitable for the study by the investigator.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05086627
| Contact: Linlin Xiao, MD | 0311-86095361 | drxiaolinlin@163.com |
| China, Hebei | |
| Fourth Hospital of Hebei Medical University | Recruiting |
| Shijiazhuang, Hebei, China, 050011 | |
| Contact: Mingxia Wang, MD 86-13933105988 mxia_wang@163.com | |
| Responsible Party: | Hebei Medical University Fourth Hospital |
| ClinicalTrials.gov Identifier: | NCT05086627 |
| Other Study ID Numbers: |
2021104 |
| First Posted: | October 21, 2021 Key Record Dates |
| Last Update Posted: | October 21, 2021 |
| Last Verified: | October 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Locally advanced rectal cancer Neoadjuvant radiotherapy Immune checkpoint inhibitors Programmed death-1 inhibitor |
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Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases |
Intestinal Diseases Rectal Diseases Capecitabine Oxaliplatin Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action Antineoplastic Agents |