Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Adenocarcinoma

Appendiceal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Cecal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Cecal Diseases

Intestinal Diseases

Small Intestinal Adenocarcinoma

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Antimetabolites

Patients were given solventinib (a "3+3" design was adopted in the dose exploration phase, with two dose levels of 200mg and 250mg for dose exploration; after the recommended dose was determined in the dose exploration phase, the dose amplification phase was entered), once a day (QD) for continuous administration

* sindilizumab, 200mg, iv every 3 weeks (Q3W)
* Capecitabine, 1000mg/m2, twice a day (BID, once in the morning and once in the evening), orally after meals, stopped for 1 week after 2 weeks of treatment;

The three-drug combination therapy was continued every 3 weeks in a cycle until patients developed disease progression or met other criteria for termination of study treatment specified in the protocol.

Surufatinib will be given 200/250 mg po. qd.

Surufatinib

Sintilimab administered IV at a dose of 200mg every 3 weeks.

Sintilimab

Capecitabine will be given 2 weeks on/1 week off (1000 mg/m2 BID po.)

Yanhong Deng, Ph.D

To explore the safety and efficacy of Surufatinib and Sintilimab in Combination With Capecitabine in Patients With Previously Treated Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma : a Single-arm, a Single-center , Phase 2 Trial. Meanwhile, Exploring the maximum tolerant dose or recommended II research dose of Surufatinib combined with a fixed dose of Sintilimab and Capecitabine using 3 + 3 dose climbing experiment.

Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma

Surufatinib and Sintilimab in Combination With Capecitabine in Patients With Previously Treated Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma : a Single-arm, a Single-center , Phase 2 Trial

The PFS is defined as the time from the start of treatment to the date of first documented PD or death as a result of any cause, whichever occurred first. When a patient was alive and without progression, PFS was censored at the date of the last disease assessment.

The percentage of subjects with total number of Complete Response (CR) + total number of Partial Response (PR).

OS is defined as the time from date of randomization to death due to any cause. Subjects still alive at the time of analysis were censored at their last date of last contact.

DCR is defined as the percentage of subjects whose best response was not Progressive Disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) (= total number of Complete Response (CR) + total number of Partial Response (PR) + total number of Stable Disease (SD); CR, PR, or SD had to be maintained for at least 28 days from the first demonstration of that rating)

Safety variables will be summarized using descriptive statistics based on adverse events collection

Sun Yat-sen University

Director of Medical Oncology, Clinical Professor

Symptoms and General Pathology

Wounds and Injuries

Nervous System Diseases

Stomach Neoplasms

Chronic Pain

Hyperthermia

Pain

Fever

Peritoneal Neoplasms

Colorectal Neoplasms

Neurologic Manifestations

Colonic Diseases

Rectal Diseases

Stomach Diseases

Abdominal Neoplasms

Peritoneal Diseases

Chronic Graft Versus Host Disease

Stomach Cancer

Patients complete questionnaires over 15 minutes and undergo pain assessments prior to surgery and at 3, 6 and 12 months after surgery. Patients also undergo blood sample collection before surgery and optionally at 3, 6 and 12 months after surgery.

Biospecimen Collection

Pain Assessment

Questionnaire Administration

Juan P Cata

This study learns if depression, anxiety, and catastrophizing (thought patterns that prompt people to expect the worst) are associated with chronic pain after surgery among patients who are scheduled to have cytoreductive surgery with intraoperative hyperthermic chemotherapy. Information from this study may improve the understanding of persistent and chronic postsurgical pain integrating multiple layers of biological and behavioral sciences.

PRIMARY OBJECTIVE:

I. To evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of chronic postsurgical pain after cytoreductive surgery with intraoperative hyperthermic chemotherapy (CRS-HIPEC).

SECONDARY OBJECTIVES:

I. To evaluate the association of preoperative psychological risk factors (depression, anxiety or catastrophizing) with the development of persistent postsurgical pain after CRS-HIPEC.

II. To evaluate the association between preoperative abnormal sensory disturbances and chronic postsurgical pain after CRS-HIPEC.

III. To assess the association of blood micro ribonucleic acids (RNAs) signatures with the development of chronic postsurgical pain after CRS-HIPEC.

IV. To determine the rate of and factors associated with persistent and chronic opioid use after CRS-HIPEC.

V. To determine the rate of persistent and chronic postsurgical anxiety and depression.

VI. To investigate changes in psychological risk factors (depression, anxiety or catastrophizing) and sensory disturbances after CRS-HIPEC overtime.

EXPLORATORY OBJECTIVE:

I. To explore the impact of perioperative (in-patient) opioid use, non-opioid analgesic use and anesthetics on the development of persistent and chronic opioid use after CRS-HIPEC.

OUTLINE:

Patients complete questionnaires over 15 minutes and undergo pain assessments prior to surgery and at 3, 6 and 12 months after surgery. Patients also undergo blood sample collection before surgery and optionally at 3, 6 and 12 months after surgery.

Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy

Prospective Evaluation of Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy in Adult Patients

Defined as pain that develops or increases in intensity compared to preoperative after cyotreductive surgery with intraoperative hyperthermic chemotherapy (CRS-HIPEC), lasts for more than 6 months.

M.D. Anderson Cancer Center

Gland and Hormone Related Diseases

Esophageal Neoplasms

Pancreatic Neoplasms

Peripheral Nervous System Diseases

Neuroendocrine Tumors

Carcinoma, Ductal

Anus Neoplasms

Neuromuscular Diseases

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Pancreatic Cancer

Bile Duct Cancer

Neuroendocrine Tumor

Gastro-enteropancreatic Neuroendocrine Tumor

Intrahepatic Cholangiocarcinoma

Pancreatic Neuroendocrine Tumor

Anal Cancer

Small Intestine Cancer

Neuroepithelioma

Oxaliplatin

Fluorouracil

Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.

Patients undergo standard of care oral cryotherapy.

Acupuncture Therapy

Acupressure Therapy

Oral Cryotherapy

Quality-of-Life Assessment

Stacey Cohen

This phase II trial investigates how well oral cryotherapy plus acupressure and acupuncture compared with oral cryotherapy alone work in decreasing chemotherapy-induced peripheral neuropathy in patients with gastrointestinal cancer who are receiving oxaliplatin-based chemotherapy. Acupressure is the application of pressure or localized massage to specific sites on the body to control symptoms such as pain or nausea. Acupuncture is the technique of inserting thin needles through the skin at specific points on the body to control pain and other symptoms. Cryotherapy uses cold temperature such as oral ice chips to prevent abnormally increased pain sensation. Giving oral cryotherapy with acupressure and acupuncture may work better in decreasing chemotherapy-induced peripheral neuropathy from oxaliplatin-based chemotherapy in patients with gastrointestinal cancer compared to oral cryotherapy alone.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients undergo acupuncture during chemotherapy infusion on day 1 and fluorouracil pump disconnect on day 3 of each biweekly chemotherapy infusion over 12 weeks. Patients also undergo self-administered acupressure over 11 minutes daily for 12 weeks and undergo standard of care oral cryotherapy.

ARM II: Patients undergo standard of care oral cryotherapy.

Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer

Pilot Study of Oral Cryotherapy vs. Oral Cryotherapy Plus Acupuncture and Acupressure to Decrease Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy for GI Cancers

Measured by the European Organization for Research and Treatment of Cancer (EORTC)-CIPN 20. Severity of CIPN will be summarized for each treatment arm, and treatment comparisons made via linear regression model with adjustment for baseline severity level. The EORTC QLQ-CIPN20 is a 20-item questionnaire that evaluates CIPN using 3 subscales that assess sensory (9 items), motor (8 items), and autonomic (3 items) symptoms and functioning with each item measured on a 1-4 scale (1, not at all; 4, very much). The sensory subscale raw scores range from 1 to 36. The CIPN-20 subscale raw scores are linearly converted to a 0-100 scale such that a high score corresponds to a worse condition or more symptoms.

Measured by Common Terminology Criteria for Adverse Events (CTCAE) version 5. Incidences of CIPN (grade 2 or higher), pain, fatigue, nausea, and anxiety will be compared between treatment arms using Chi-squared or Fisher's exact tests as appropriate.

The Neuropen is used to assess touch and pressure perception as well as protective pain and sharpness sensation. Touch and pressure sensation will be assessed using a 10-g monofilament on the subject's dominant foot. Pain and subjective sharpness sensation will be assessed using the 40-g Neurotip on the dominant foot. Loss of pain and pressure sensation are associated with increased CIPN.

A study-specific 128-Hz tuning fork will be used to assess vibration sensation on dominant lower extremity and dominant upper extremity sites. If the patient feels the vibration for 15 seconds or longer, this is defined as normal. If the patient feels the vibration less than 15 seconds, this is defined as absent or decreased vibration sensation. Vibration sensation is lost sooner in CIPN, which means that shorter duration of vibration scores are associated with increased CIPN.

Adherence to acupuncture treatment among patients in the intervention arm will be described as a proportion with 95% confidence interval. Reasons for treatment non-adherence and delivered dose intensity of chemotherapy will be noted.

Measured by patient-reported (National Cancer Institute \[NCI\] Patient Reported Outcomes \[PRO\]-CTCAE, Brief Pain Inventory \[BPI\], oral dysesthesia) and provider-assessed (CTCAE version 5) grading scales.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surufatinib and Sintilimab in Combination With Capecitabine for Metastatic Adenocarcinoma of Small Intestine or Appendix Carcinoma	NCT05472948	Adenocarcinoma ... Appendix Carcin... Metastatic	Surufatinib Sintilimab Capecitabine	18 Years - 70 Years	Sun Yat-sen University
Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy	NCT05083338	Appendix Carcin... Carcinomatosis Colorectal Carc... Gastric Carcino... Malignant Perit... Malignant Solid...	Biospecimen Col... Pain Assessment Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Psychological, Psychophysical and Epigenetic Determinants of Chronic Pain After Cytoreductive - Hyperthermic Intraoperative Chemotherapy	NCT05083338	Appendix Carcin... Carcinomatosis Colorectal Carc... Gastric Carcino... Malignant Perit... Malignant Solid...	Biospecimen Col... Pain Assessment Questionnaire A...	18 Years -	M.D. Anderson Cancer Center
Oral Cryotherapy Plus Acupressure and Acupuncture Versus Oral Cryotherapy for Decreasing Chemotherapy-Induced Peripheral Neuropathy From Oxaliplatin-Based Chemotherapy in Patients With Gastrointestinal Cancer	NCT04505553	Appendix Carcin... Colon Carcinoma Esophageal Carc... Gastric Carcino... Liver and Intra... Malignant Diges... Pancreatic Carc... Rectal Carcinom... Small Intestina... Anal Carcinoma Digestive Syste... Digestive Syste... Pancreatic Neur...	Acupuncture The... Acupressure The... Oral Cryotherap... Questionnaire A... Quality-of-Life...	18 Years -	University of Washington

Spots Global Cancer Trial Database for appendix carcinoma