Preoperative Radiotherapy and Anlotinib With or Without Penpulimab for Soft Tissue Sarcoma (SPARE-04)
A Prospective Multicenter Randomized Controlled Study of Preoperative Radiotherapy Combined With Targeted Therapy With or Without Immunotherapy for Soft Tissue Sarcoma
Soft tissue sarcoma is a rare cancer that often requires surgery combined with radiotherapy. Preoperative radiotherapy can improve the chance of complete tumor removal and limb preservation, but some patients still experience local recurrence, distant metastasis, or poor tumor response.
This is a prospective, multicenter, randomized phase II study for patients with localized soft tissue sarcoma of the extremity or trunk who need preoperative radiotherapy. Participants will be randomly assigned to receive preoperative radiotherapy plus anlotinib, or preoperative radiotherapy plus anlotinib and penpulimab. Surgery will be performed after completion of neoadjuvant treatment according to the study protocol.
The main purpose of this study is to evaluate whether adding penpulimab to preoperative radiotherapy and anlotinib can improve 3-year disease-free survival. The study will also assess pathological response, wound complications, treatment-related adverse events, local control, distant metastasis-free survival, overall survival, limb function, quality of life, and exploratory biomarkers related to treatment response.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Preoperative radiotherapy is an established treatment approach for patients with localized soft tissue sarcoma of the extremity or trunk, particularly when limb preservation and complete surgical resection are important treatment goals. However, the pathological response to preoperative radiotherapy alone remains limited in some patients, and local recurrence or distant metastasis can still occur after multidisciplinary treatment.
Anlotinib is a multitarget tyrosine kinase inhibitor with antiangiogenic activity and has shown clinical activity in soft tissue sarcoma. Immune checkpoint blockade may further enhance antitumor effects when combined with radiotherapy and antiangiogenic therapy by modulating the tumor microenvironment. The optimal patient population and risk-benefit profile of this combined neoadjuvant strategy require prospective evaluation.
This study is designed to compare preoperative radiotherapy plus anlotinib with preoperative radiotherapy plus anlotinib and penpulimab in patients with localized soft tissue sarcoma who are candidates for neoadjuvant treatment followed by surgery. The study will evaluate whether the addition of penpulimab improves disease control while maintaining acceptable safety, surgical feasibility, and postoperative wound healing.
Participants will receive protocol-defined neoadjuvant treatment before surgery and will be followed after surgery for disease outcomes, safety, limb function, quality of life, and translational biomarker analyses. The study also includes collection and analysis of clinical, imaging, pathological, and molecular data to explore potential predictors of treatment response and resistance.
연구 유형
연구 유형
등록 (추정된)
등록
단계
단계
- 2 단계
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Ning-Ning Lu
- 전화번호: +868611804268
- 이메일: Ning-Ning.Lu@hotmail.com
연구 연락처 백업
- 이름: Shijie Yang
- 이메일: ysj14@mails.tsinghua.edu.cn
연구 장소
-
-
Beijing Municipality
-
Beijing, Beijing Municipality, 중국, 100021
- Cancer Hospital, National Cancer Center, CAMS & PUMC
-
-
참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Primary or recurrent soft tissue sarcoma of the extremity or trunk with intermediate- to high-grade disease and tumor size >=5 cm or deep-seated tumor, for which radiotherapy is recommended after multidisciplinary evaluation.
- Age >=15 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3.
- Histologically confirmed soft tissue sarcoma.
- At least one evaluable lesion.
- Able to tolerate radiotherapy, anlotinib, and penpulimab treatment.
- Female participants of childbearing potential, or male participants with female partners of childbearing potential, must agree to use effective contraception during the treatment period and for 6 months after the last dose of study treatment.
- Able to provide written informed consent.
- Able and willing to comply with follow-up.
Exclusion Criteria:
- No gross tumor remaining after unplanned tumor resection performed at another hospital.
- Contraindications to targeted therapy or immunotherapy due to comorbidities, including allergy, autoimmune disease, active bleeding, ulcer, intestinal perforation, intestinal obstruction, uncontrolled hypertension, New York Heart Association class III-IV cardiac dysfunction, or severe hepatic or renal dysfunction.
- Dermatofibrosarcoma protuberans, desmoid fibromatosis, tenosynovial giant cell tumor, or other locally aggressive diseases.
- Benign tumors.
- Sarcoma subtypes for which chemotherapy is recommended as the preferred neoadjuvant treatment according to guidelines, such as embryonal rhabdomyosarcoma or Ewing sarcoma.
- Lipoma-like liposarcoma or well-differentiated liposarcoma.
- New malignant tumor within 5 years before enrollment, except cervical carcinoma in situ, early-stage basal cell carcinoma of the skin, or early-stage lung cancer.
- Soft tissue sarcoma that can be cured by wide local excision alone.
- Prior radiotherapy to the same anatomical site.
- Other severe medical comorbidities that would preclude surgery or participation in this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
활성 비교기: Arm A: Preoperative Radiotherapy Plus Anlotinib
Preoperative Radiotherapy Plus Anlotinib
|
Anlotinib will be administered orally at 12 mg once daily, starting 1 week before radiotherapy and continuing until 4 weeks after completion of radiotherapy, on a 2-weeks-on and 1-week-off schedule for 3 cycles.
Dose modification will be performed according to protocol-defined toxicity management criteria.
Preoperative radiotherapy will be delivered according to the protocol-defined target volume and dose schedule before surgery.
Radiotherapy may be given as conventional fractionation or moderate hypofractionation according to the study protocol.
다른 이름들:
Surgery will be performed after completion of neoadjuvant treatment.
The goal of surgery is complete tumor resection while preserving organ and limb function whenever feasible, according to protocol-defined surgical principles.
|
|
실험적: Arm B: Preoperative Radiotherapy Plus Anlotinib and Penpulimab
Preoperative Radiotherapy Plus Anlotinib and Penpulimab
|
Anlotinib will be administered orally at 12 mg once daily, starting 1 week before radiotherapy and continuing until 4 weeks after completion of radiotherapy, on a 2-weeks-on and 1-week-off schedule for 3 cycles.
Dose modification will be performed according to protocol-defined toxicity management criteria.
Preoperative radiotherapy will be delivered according to the protocol-defined target volume and dose schedule before surgery.
Radiotherapy may be given as conventional fractionation or moderate hypofractionation according to the study protocol.
다른 이름들:
Surgery will be performed after completion of neoadjuvant treatment.
The goal of surgery is complete tumor resection while preserving organ and limb function whenever feasible, according to protocol-defined surgical principles.
Penpulimab will be administered intravenously at 200 mg every 3 weeks, starting 1 week before radiotherapy and continuing until 4 weeks after completion of radiotherapy, for a total of 3 cycles.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
3-Year Disease-Free Survival
기간: From randomization to 3 years after randomization
|
Disease-free survival is defined as the time from randomization to the first occurrence of local recurrence, distant metastasis, new malignancy, or death from any cause.
Participants without an event will be censored at the date of last follow-up.
|
From randomization to 3 years after randomization
|
공동 작업자 및 조사자
스폰서
스폰서
수사관
수사관
- 수석 연구원: Ning-Ning Lu, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- NCC6371
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .